2022 has been marked by the first year of leadership under CEO Joaquin Duato and the anticipated separation of the company’s consumer health business.  

By Andrew Humphreys • andrew.humphreys@medadnews.com

Johnson & Johnson

One Johnson & Johnson Plaza

New Brunswick, NJ 08933

732-524-0400 • jnj.com

Best-selling Rx products

All sales are in millions of dollars.

2021 sales

• Stelara $9,134 
• Darzalex $6,023 
• Imbruvica $4,369 
• Invega Sustenna/Xeplion, Invega Trinza/ Invega Trevicta $4,022 
  
• Remicade $3,190 
• Xarelto $2,438 
• COVID-19 Vaccine $2,385 
• Zytiga/abiraterone acetate $2,297  
• Simponi, Simponi Aria $2,276 
• Tremfya $2,127 
• Prezista, Prezcobix/ Rezolsta, Symtuza $2,083 
  
• Opsumit $1,819 
• Erleada $1,291 
• Uptravi $1,237 
• Edurant/rilpivirine $994 
• Concerta/methylphenidate $667  
• Risperdal Consta $592 
• Invokana, Invokamet $563

 1H 2022 sales

• Stelara $4,887 
• Darzalex $3,842 
• Invega Sustenna/Xeplion, Invega Trinza/ Invega Trevicta $2,102 
  
• Imbruvica $2,008 
• Remicade $1,310 
• Tremfya $1,187 
• Simponi, Simponi Aria $1,137 
• Xarelto $1,117 
• Zytiga/abiraterone acetate $1,044 
• COVID-19 Vaccine $1,001 
• Prezista, Prezcobix/Rezolsta, Symtuza $965 
  
• Opsumit $881 
• Erleada $850 
• Uptravi $653 
• Edurant/rilpivirine $473 
• Concerta/methylphenidate $318  
• Risperdal Consta $254 

Outcomes Creativity Index Score: 26

• Manny Awards — N/A
• Cannes Lions — 2
• Clio Health — 3
• Creative Floor Awards — 15
• London International Awards – N/A
• MM+M Awards — 4
• One Show — 2

The onset of 2022 brought a new chief executive officer to Johnson & Johnson as outgoing CEO Alex Gorsky handed over the reins to Joaquin Duato. 

“In our industry, impact can and must always be quantified in numbers … The one that stands out most to me in 2021 is not a sales figure or market share. It’s our record investment of $14.7 billion in research and development – a 21 percent increase over our previous all-time-high investment in 2020,” stated Gorsky, who now serves as executive chairman of J&J. “R&D isn’t just the foundation of growth for our company – it’s the engine driving scientific progress in creating a healthier world. Johnson & Johnson has made an investment in innovation every year since 1886. And in doing so, every year we have taken on the responsibility of defining what we think healthcare can accomplish next.”

Behind Johnson & Johnson’s world-class pharma scientists, 2021 saw the advancement of exciting new medicines for some of the hardest-to-treat diseases, with the FDA approving two new products: Rybrevant (amivantamab-vmjw), the first targeted treatment for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations, and Ponvory (ponesimod) for treating adults with relapsing forms of multiple sclerosis. J&J also continued to advance key pipeline programs, including the BCMA-directed CAR-T cell therapy program and the company’s entry into gene therapy with a concentration on retinal diseases.

2021 also saw the launch of more than 400 new Consumer Health products as the J&J segment’s employees prioritized the health of the planet via innovation. Also, toward the end of last year, management announced the planned separation of Johnson & Johnson’s Consumer Health business.

New consumer health company

J&J during November 2021 unveiled a plan to separate the Consumer Health business with the intention to create a new, publicly traded company. J&J is targeting completion of the intended separation in 2023, 18 to 24 months after the initial announcement. Management said the separation would create two worldwide leaders – the new Johnson & Johnson and the New Consumer Health Company – each better positioned to deliver improved health outcomes for patients and consumers via innovation, pursue more targeted business strategies and accelerate growth.

According to J&J executives, the intended separation is anticipated to create value for all stakeholders by aiming to achieve the following key goals: increase management focus, resources, agility and speed to effectively address differing industry trends and to better meet the needs of the new J&J and the New Consumer Health Company patients and consumers; further focus capital allocation based on the objectives of each independent company; provide each company with a compelling financial profile that more accurately reflects the strengths and opportunities of each business and, as a result, offers investors a more targeted investment opportunity; and align corporate and operational structures so each company is better able to drive growth and value creation.

Management says the New Consumer Health Company will be a global leader, touching the lives of more than 1 billion consumers worldwide every day through iconic brands such as Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s, and Band-Aid and continuing a legacy of innovation.

According to management, the new Johnson & Johnson would remain the world’s largest and most diverse healthcare company and continue a commitment to lead in global healthcare R&D, with a portfolio that includes strong Pharmaceutical and Medical Device capabilities concentrated on advancing the standard of care through innovation and technology.

Thibaut Mongon was appointed CEO designate for the future-listed New Consumer Health Company during May 2022. At that time, Paul Ruh was named chief financial officer designate. Larry Merlo was tapped as non-executive chair designate in August 2022. Previously president and CEO of CVS Health, Merlo brings more than 30 years of purpose-driven and transformative health leadership to the board for the planned new company.

“It is an exciting time for the business and the industry at large,” Merlo stated. “With an iconic portfolio of consumer health brands, legacy of scientific rigor, category-creating innovation, and a digital-first mindset, there is no doubt that the planned New Consumer Health Company will be an industry force. I look forward to being part of this journey with Thibaut and the leadership team and making a positive impact on the health and wellness of over 1 billion people around the world that rely on these products every day.”

As this magazine was going to press, Johnson & Johnson announced Kenvue as the name for the planned New Consumer Health Company. 

$5 Billion Share Repurchase Program

On Sept. 14, 2022, Johnson & Johnson announced that the board of directors had authorized the repurchase of up to $5 billion of the company’s common stock. “The last few years have demonstrated the resilience of Johnson & Johnson. With continued confidence in our business and pipeline, the board of directors and management team believe that company shares are an attractive investment opportunity,” Duato stated. “With our strong cash flow and lowest level of net debt in five years, we have the ability to invest in innovation, grow our dividend, execute strategic acquisitions, and take this action to deliver shareholder returns and drive long-term growth.”

Financial performance

J&J’s global sales for the first fiscal six months of 2022 totaled $47.4 billion, representing growth of 4.0 percent, including an operational increase of 7.8 percent as compared to first-half 2021. Currency fluctuations had a negative impact of 3.8 percent during 2022’s first six months. The net impact of acquisitions and divestitures on global operational sales growth was a negative 0.2 percent.

Sales by U.S. companies during first-half 2022 amounted to $23.6 billion, with year-over-year growth of 2.5 percent. Management said the net impact of acquisitions and divestitures on the U.S. operational sales growth was a negative 0.1 percent. Sales by international companies totaled $23.8 billion, an increase of 5.5 percent versus first-half 2021, including an operational increase of 13.3 percent, and a negative currency impact of 7.8 percent. The net impact of acquisitions and divestitures on the international operational sales growth was negative 0.3 percent.

Sales by companies in Europe generated sales growth of 9.3 percent during January–June 2022, which included an operational increase of 20.1 percent and a negative currency impact of 10.8 percent. Sales by companies in the Western Hemisphere, excluding the United States, produced 8.1 percent growth, which included an operational increase of 9.9 percent, and a negative currency impact of 1.8 percent. J&J reported that sales by companies in the Asia-Pacific, Africa region during 2022’s first six months fell 0.2 percent, including an operational increase of 5.6 percent and a negative currency impact of 5.8 percent.

Pharma segment sales for J&J during the first six months of 2022 increased to $26.2 billion, representing 6.5 percent year-over-year growth, with an operational increase of 10.8 percent and a 4.3 percent negative currency impact. The company reported that U.S. Pharmaceutical sales improved 3.6 percent versus the same period in 2021. International Pharmaceutical sales rose 10.0 percent, including operational growth of 19.4 percent and a negative currency impact of 9.4 percent. For the first six months of 2022, the net impact of acquisitions and divestitures on the Pharmaceutical segment operational sales growth was a negative 0.1 percent.

The Darzalex (daratumumab) franchise for the treatment of multiple myeloma generated sales of $3.84 billion during the first fiscal half of 2022.

During Q2 2022, Pharmaceutical worldwide adjusted operational sales increased 12.4 percent, driven by Darzalex (daratumumab), a biologic for the treatment of multiple myeloma; Stelara (ustekinumab), a biologic for treating various immune-mediated inflammatory diseases; Erleada (apalutamide), a next-generation androgen receptor inhibitor for treating prostate cancer; Tremfya (guselkumab), a biologic for the treatment of moderate-to-severe plaque psoriasis and active psoriatic arthritis; and the long-acting, injectable atypical antipsychotics Invega Sustenna/Xeplion and Invega Trinza/Trevicta (paliperidone palmitate) for the treatment of schizophrenia in adults. An additional Q2 sales growth contributor was the Janssen COVID-19 Vaccine (Ad26.COV2.S) for the prevention of the SARS-CoV-2 virus. According to J&J, this growth was partially offset by sales decreases of the biologic Remicade (infliximab) for the treatment of several immune-mediated inflammatory diseases and the oral, once daily therapy Imbruvica (ibrutinib) for treating certain B-cell malignancies, a form of blood of lymph node cancer.

J&J’s MedTech segment generated sales of $13.9 billion during first-half 2022, representing 2.3 percent growth over the one-year-earlier time frame, with an operational increase of 5.9 percent and a negative currency impact of 3.6 percent. U.S. MedTech sales rose 3.5 percent versus first-half 2021. International MedTech sales improved 1.2 percent, including an operational increase of 8 percent and a negative currency impact of 6.8 percent. Net impact of acquisitions and divestitures on MedTech’s operational sales growth was a negative 0.1 percent.

MedTech worldwide adjusted operational sales for the company rose 3.4 percent, driven primarily by contact lenses and surgical vision products in J&J’s Vision franchise, and electrophysiology products in the Interventional Solutions business. Growth was partially offset by COVID-19 related mobility restrictions in certain regions, according to management. 

Consumer Health segment sales for J&J during the first six months of 2022 fell to $7.4 billion, down 1.4 percent versus the one-year-earlier period, including operational growth of 1.6 percent and a negative currency impact of 3.0 percent. U.S. Consumer Health segment sales dropped 3.5 percent year-over-year. International Consumer Health segment sales improved by 0.3 percent, including operational growth of 5.7 percent and a negative currency impact of 5.4 percent. The net impact of acquisitions and divestitures on Consumer Health’s operational sales growth in the 2022 first half was a negative 0.6 percent.

In the 2022 second quarter, Consumer Health global adjusted operational sales grew 2.9 percent. Major contributors to growth included upper respiratory and analgesic products in the international market of J&J’s OTC franchise as well as Imodium in digestive health products and Neutrogena in international Skin Health/Beauty.

“Our solid second-quarter results across Johnson & Johnson reflect the strength and resilience of our company’s market leadership in the midst of macroeconomic challenges,” Duato said. “I am continually energized by the focus and passion of my Johnson & Johnson colleagues and their dedication toward delivering transformative healthcare solutions to patients and consumers around the world.”

In reporting J&J’s first-half 2022 results, the company maintained full-year guidance at midpoints for adjusted operational sales and adjusted operational earnings per share; management said the strengthening U.S. dollar was impacting the estimate for reported results. As of July 2022, the company’s operational sales outlook for full-year 2022 was $97.3 to $98.3 billion, which would represent a 6.5 to 7.5 percent increase versus 2021. Estimated reported sales for 2022 were $93.3 to $94.3 billion, which would mark a 2.1 to 3.1 percent improvement over the 2021 amount. As of July 2022, the full-year outlook for adjusted EPS (diluted) was $10.00 to $10.10, which would be a 2.1 to 3.1 percent increase compared to the prior year.

Covid-19 vaccine

The World Health Organization (WHO) issued an updated Emergency Use Listing (EUL) for the Johnson & Johnson COVID-19 vaccine in April 2022, recommending the vaccine for use in boosted regimens in persons aged 18 years and older. According to the updated EUL, the Johnson & Johnson COVID-19 vaccine is recommend for use both as a homologous booster (same vaccine) after a single-dose primary vaccination and as a heterologous booster (“mix-and-match” vaccines) following a primary mRNA vaccine regimen. The WHO additionally recommended to extend the shelf-life of thawed vaccine stored at 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) to 11 months within the vaccine’s maximum 24-month shelf-life when stored at -25 to -15 degrees Celsius.

With WHO’s updated guidance, J&J said in a homologous regimen the company’s vaccine may be administered for both primary vaccination of a single dose and as a booster shot as soon as two months later. In a heterologous regimen, the vaccine may be administered as a booster following the completion of primary vaccination with an approved mRNA COVID-19 vaccine, at the same dosing interval as that authorized for a booster dose of the vaccine used for primary vaccination.

The Johnson & Johnson COVID-19 vaccine booster additionally received Emergency Use Authorization from the FDA and a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).

J&J’s COVID-19 vaccine is made available globally via COVAX, the African Vaccine Acquisition Trust (AVAT) and other supply deals with governments, and access to the vaccine for some of the world’s most vulnerable people has been enabled through the COVAX Humanitarian Buffer. 

J&J struck a deal in March 2022 to enable the first COVID-19 vaccine to be manufactured and made available by an African company for people living in Africa, with the goal of increasing COVID-19 vaccination rates across the continent.

Product Approvals & pipeline updates

The Janssen Pharmaceutical Companies of Johnson & Johnson continue to develop a robust oncology portfolio and pipeline of investigational therapies. Janssen remains concentrated on developing and delivering tailored immunotherapy regimens to treat patients with multiple myeloma. Already a market leader in the multiple myeloma arena with Darzalex as one of the word’s best-selling prescription drugs, Janssen added a pair of new medicines to the multiple myeloma (MM) product portfolio during 2022 for help in treating the incurable blood cancer. 

Carvykti (ciltacabtagene autoleucel; cilta-cel) won FDA clearance in February 2022 for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody. The approval is based on clinical data from the pivotal CARTITUDE-1 trial, which included patients who had received a median of six previous treatment regimens (range, 3-18), and had previously received a PI, an IMiD and an anti-CD38 monoclonal antibody. 

The European Commission (EC) granted conditional marketing authorization during May 2022 for Carvykti for treating adults with RRMM who have received at least three prior therapies, including an IMiD, a PI and an anti-CD38 antibody, and have shown disease progression on the last therapy.

A chimeric antigen receptor T-cell (CAR-T) therapy, Carvykti features two B-cell maturation antigen (BCMA)-targeting single domain antibodies. In the pivotal CARTITUDE-1 trial, one-time treatment with ciltacabtagene autoleucel led to deep and durable responses, with 98 percent (95 percent Confidence Interval [CI], 92.7-99.7) of patients with RRMM responding to therapy (98 percent overall response rate [ORR] (n=97). Additionally, 78 percent of patients who responded experienced a stringent complete response.

There are several Phase III studies assessing Carvykti in earlier treatment settings, including first-line. Janssen Biotech entered into an exclusive worldwide license and collaboration agreement with Legend Biotech USA to develop and commercialize cilta-cel during December 2017.

Janssen’s Tecvayli (teclistamab) received the new medicine’s first approval anywhere worldwide in August 2022. The EC authorized the first-in-class bispecific antibody for treating patients with multiple myeloma. Conditional marketing authorization was granted for Tecvayli as monotherapy for treating adults with RRMM. Patients must have received at least three previous therapies, including an IMiD, a PI and an anti-CD38 antibody, and have demonstrated disease progression on the prior therapy.

Research shows that teclistamab redirects CD3-positive T-cells to B-cell maturation antigen (BCMA)-expressing myeloma cells to induce the killing of tumor cells. An off-the-shelf (ready to use) subcutaneously administered therapy, teclistamab induced deep and rapid responses in triple-class exposed patients with RRMM in clinical studies. The medication is being tested in several monotherapy and combination clinical trials.

The FDA and the EC each granted teclistamab Orphan Drug Designation for treating multiple myeloma during 2020. In January 2021 and May 2021, teclistamab received a PRIority MEdicines (PRIME) designation by the EMA and Breakthrough Therapy Designation (BTD) by the FDA, respectively. PRIME offers enhanced interaction and early dialog to optimize drug development plans and speed up assessment of cutting-edge, scientific advances that target a high unmet medical need. The FDA granted teclistamab Priority Review Designation during December 2021.

Carvykti and Tecvayli have joined Janssen’s lineup of MM medicines headlined by Darzalex and Darzalex Faspro (daratumumab and hyaluronidase-fihj), which have been approved in eight indications, three of which are in the frontline setting, including for newly diagnosed patients who are transplant eligible as well as those who are ineligible. Darzalex Faspro is the only subcutaneous CD38-directed antibody worldwide approved to treat MM patients. The product is co-
formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s Enhanze drug delivery technology. Darzalex Faspro became the first U.S.-approved therapy for light chain amyloidosis during January 2021. 

Janssen Biotech entered into an exclusive global license and development deal during August 2012 with Genmab to develop, manufacture, and commercialize Darzalex.

Janssen is also developing the new drug candidate talquetamab as a treatment for adult patients with relapsed or refractory multiple myeloma. The novel GPRC5DxCD3 bispecific antibody gained BTD from the FDA in June 2022 based upon clinical results from the Phase I/II MonumenTAL-1 trial.

The BTD for talquetamab was granted for treating adults with RRMM who have previously received at least four prior lines of therapy, including a PI, an IMiD and an anti-CD38 antibody. The investigational, off-the-shelf, T-cell redirecting bispecific antibody targets both GPRC5D, a novel drug target, on multiple myeloma cells and CD3 on T-cells. The June 2022 milestone represented the 12th BTD received by Janssen in oncology and the third such designation for the company’s portfolio of bispecific antibodies.

In the area of leukemia and lymphoma, Janssen continues to study Imbruvica with the goal of addressing unmet clinical needs and helping to improve outcomes for patients living with mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL).

An oral once-daily therapy approved for use in treating certain B-cell malignancies, Imbruvica (ibrutinib) sales during first-half 2022 totaled more than $2 billion.

Imbruvica became the first Bruton’s tyrosine kinase inhibitor (BTKi) treatment for pediatric patients with chronic graft-versus-host disease (cGVHD) upon receiving U.S. marketing clearance in August 2022. The FDA approved the product for the treatment of pediatric patients 1 year and older with cGVHD after failure of one or more lines of systemic therapy. This milestone marks Imbruvica’s first pediatric indication and the introduction of a new oral suspension formulation for patients ages 1 to less than 12 years old. Imbruvica represents the first FDA-approved therapy for these younger patients who previously had no marketed treatment options for the life-
threatening disease.

Ibrutinib is jointly developed and commercialized by Janssen Biotech and AbbVie company Pharmacyclics. The medication blocks the BTK protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread. By blocking BTK, the drug may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation. 

Ibrutinib is approved for marketing in 100-plus countries and has been used to treat more than 250,000 patients. There are more than 50 company-sponsored clinical studies, including 18 Phase III trials, over 11 years assessing the efficacy and safety of ibrutinib. During October 2021, ibrutinib was added to the World Health Organization’s Model Lists of Essential Medicines (EML), which refers to products that address worldwide health priorities and which should be available and affordable for all.

Imbruvica originally received FDA approval in November 2013, and as of August 2022 is indicated in the United States for adults in six disease areas, including five hematologic cancers. Other U.S.-approved indications include CLL/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), MCL, and marginal zone lymphoma (MZL).

The EC in August 2022 approved a new treatment option with Imbruvica in an oral fixed-duration combo with venetoclax (I+V) for adults with previously untreated CLL. The marketing authorization is based on the pivotal Phase III GLOW and Phase II CAPTIVATE trial results, which evaluated the efficacy and safety of ibrutinib plus venetoclax in patients with previously untreated CLL. Imbruvica represents the first all-oral, once-daily, fixed-duration BTK inhibitor-based regimen for first-line treatment of CLL.

Ibrutinib was initially approved by the EC during 2014, and approved uses in Europe include other indications for CLL in addition to MCL and WM.

The Janssen Pharmaceutical Companies announced in June 2022 primary results from the Phase III SHINE trial, which showed that the combination of once-daily oral Imbruvica plus bendamustine-rituximab (BR) and rituximab maintenance significantly reduced the risk of disease progression or death by 25 percent compared to patients who received placebo plus BR and rituximab maintenance in patients aged 65 years or older with newly diagnosed MCL. Janssen says this trial is one of the largest clinical studies ever performed in first-line MCL and the first for a BTKi. The clinical data were published in the New England Journal of Medicine on June 3. 

The biologic Stelara (ustekinumab), intended for the treatment of various immune-mediated inflammatory diseases, was Johnson & Johnson’s top-selling prescription medicine during the first six months of 2022 with sales of $4.89 billion.

Stelara (ustekinumab) garnered U.S. marketing clearance on July 29, 2022, as a treatment for pediatric patients with active psoriatic arthritis (PsA). U.S. regulators approved the medicine for treating pediatric patients 6 years of age and older with PsA, which affects five to eight percent of children and adolescents with chronic inflammatory arthritis. As the first biologic targeting both cytokines interleukin (IL)-12 and IL-23, Stelara provides a new therapeutic option for children at least 6 years of age living with PsA.

Two of the four indications for Stelara include pediatric patients, further expanding the drug’s treatment profile since initially receiving approval in September 2009 for adults living with moderate-to-severe plaque psoriasis (PsO). The fully human monoclonal antibody selectively inhibits IL-12 and IL-23, two cytokines believed to play a significant role in tempering the overactive inflammatory response in several autoimmune diseases. As one of the world’s top-selling prescription drugs, Stelara is marketed in the United States for treating moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis.

Cabenuva (rilpivirine and cabotegravir) was approved by U.S. regulators in March 2022 for adolescents, expanding the indication of the first complete long-acting injectable HIV regimen. The medicine was approved for treating HIV-1 in virologically suppressed adolescents (HIV-1 RNA less than 50 copies per milliliter [c/mL]) who are 12 years of age or older, weigh at least 35 kg and are on a stable antiretroviral regimen, with no history of treatment failure, nor known or suspected resistance to either cabotegravir or rilpivirine.

Jointly developed as part of a collaboration with ViiV Healthcare, Cabenuva is the first complete long-acting HIV-1 treatment regimen to be made available for eligible adolescents. Cabenuva is available as a once-monthly or every-two-months treatment for HIV-1 in virologically suppressed adults and adolescents. The product contains ViiV’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial, a product of Janssen Sciences Ireland Unlimited Company, one of the Janssen Pharmaceutical Companies.

The FDA approved Cabenuva during January 2021 to be administered every month to adults living with HIV-1. In February 2022, the U.S. regulatory agency gave clearance for an expanded label for the drug to be administered every two months to adults living with HIV-1. The FDA approved a label update in March 2022 making the oral lead-in period optional for adults living with HIV-1 who planned to start the injectable treatment regimen. The oral lead-in period is additionally optional for adolescents.

The once-monthly and every-two-months version of cabotegravir and rilpivirine injectable treatment for adults has been cleared for marketing by the European Commission, Health Canada, the Australia Therapeutic Goods Administration, and the Swiss Agency for Therapeutic Products. Regulatory reviews continue with other filings planned throughout 2022.

Data for the blockbuster brand Tremfya was reported in September 2022 from the ongoing Phase IIIb GUIDE trial, which is designed to understand the impact of early intervention and potential dosing interval flexibility on the long-term disease course in adults with moderate-to-severe PsO. These new data showed that “super responders” to guselkumab who received every-16-week dosing maintained disease control (absolute Psoriasis Area and Severity Index [PASI] score <3) at a rate that was non-inferior to the approved every-eight-week dosing interval (92.6 percent vs 91.9 percent, P=0.001), meeting the clinical trial’s week 68 primary endpoint. 

Developed by Janssen, guselkumab represents the first marketed fully human monoclonal antibody that selectively binds to the p19 subunit of interleukin-23 and inhibits its interaction with the IL-23 receptor. Tremfya is available in the United States, Canada, Japan, and other countries for treating adult patients with moderate-to-severe PsO who may benefit from taking systemic therapy (injections or pills) or phototherapy (treatment using ultraviolet light), and for the treatment of adults with active PsA Tremfya is the first fully human selective IL-23 inhibitor therapy approved in the United States for adults with moderate-to-severe PsO and adults with PsA. Guselkumab is approved in the EU for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy, and alone or in combination with methotrexate (MTX) for treating PsA in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy. 

Janssen reported in June 2022 data from Phase III trials showing patients treated with Tremfya achieved consistent, long-term efficacy through two years across the domains of PsA – including joint, skin, enthesitis, dactylitis, spinal pain and disease severity endpoints – irrespective of baseline characteristics. Further analyses demonstrated the medicine provided patients with sustained improvements in measures of health-related quality of life (HRQoL), including fatigue, pain, and work productivity.

Guselkumab is also being tested in Phase III studies in adults with moderately to severely active Crohn’s disease (EudraCT 2017-002195-13) and adults with moderately to severely active ulcerative colitis (EudraCT 2018-004002-25).

In the area of prostate cancer, the prospectively designed Phase III MAGNITUDE trial is testing the safety and efficacy of the combination of niraparib and abiraterone acetate (which is marketed by Janssen as Zytiga) plus prednisone in patients with homologous recombination repair (HRR)-gene mutated metastatic castration-resistant prostate cancer (mCRPC). The clinical data investigated HRR gene alterations beyond BRCA1/2, including PALB 2, CHEK2 and other mutations. Also, the Phase III ATLAS trial is evaluating if the addition of Erleada to a gonadotropin-releasing hormone agonist (GnRH) in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival. 

Niraparib is an orally administered, poly-ADP ribose polymerase (PARP) inhibitor being investigated by Janssen as a treatment for patients with prostate cancer. Ongoing clinical trials besides MAGNITUDE include the Phase III AMPLITUDE study exploring niraparib in combination with abiraterone acetate plus prednisone in a biomarker-selected patient population with metastatic castration-
sensitive prostate cancer (mCSPC); and QUEST, a Phase Ib/II trial of niraparib combination therapies for treating mCRPC. Janssen announced during April 2022 the filing of a Marketing Authorization Application (MAA) to the EMA seeking approval of niraparib in combination with abiraterone acetate, in the form of a dual-action tablet plus prednisone, based on the results of the Phase III MAGNITUDE trial for patients with prostate cancer who have progressed to mCRPC and are positive for homologous recombination repair (HRR) gene alterations.

The androgen receptor inhibitor Erleada is indicated for treating patients with non-metastatic castration-resistant prostate cancer (nmCRPC) and for treating patients with mCSPC. The product received FDA approval for nmCRPC during February 2018, and was approved for mCSPC in September 2019. More than 50,000 patients have been treated with Erleada around the globe.

New real-world evidence data were presented in February 2022 by Janssen showing the initiation of Erleada results in high rates of rapid and deep prostate-specific antigen (PSA) response among patients with mCSPC. In a separate post-hoc analysis of the registrational Phase III SPARTAN and TITAN trials, rapid and deep PSA responses with the drug were associated with improvement in patient-reported outcomes (PROs) related to quality of life, physical wellbeing, pain, and fatigue intensity.

Balversa (erdafitinib) is being evaluated in multiple clinical studies including the Phase III THOR (NCT03390504) trial testing the medicine versus standard of care, consisting of chemotherapy (docetaxel or vinflunine) or anti-PD-1 agent pembrolizumab, in participants with advanced urothelial cancer and selected FGFR aberrations with disease progression following one previous line of therapy. Additionally, the Phase II THOR-2/BLC2003 trial (NCT04172675) is examining Balversa compared to investigator choice of intravesical chemotherapy in participants who received Bacillus Calmette-Guérin and recurred with high-risk non-muscle-invasive bladder cancer.

Balversa is a once-daily, oral FGFR kinase inhibitor FDA-approved for the treatment of adults with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible FGFR3 or FGFR2 genetic alterations and has progressed during or following at least one line of platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. Janssen entered into an exclusive global license and collaboration deal with Astex Pharmaceuticals during 2008 to develop and commercialize the drug.

Rybrevant is being evaluated in multiple clinical studies, including the Phase I/Ib CHRYSALIS-2 (NCT04077463) trial examining the combination of the product with lazertinib in patients who have progressed after treatment with osimertinib and chemotherapy; as first-line therapy in untreated advanced EGFR-mutated NSCLC in the Phase III MARIPOSA (NCT04487080) trial evaluating amivantamab in combination with lazertinib; the planned Phase III MARIPOSA-2 (NCT04988295) study to test the efficacy of lazertinib, Rybrevant and carboplatin-pemetrexed versus carboplatin-pemetrexed in patients with locally advanced or metastatic EGFR exon 19 deletion or exon 21 L858R substitution NSCLC after osimertinib failure; the Phase III PAPILLON (NCT04538664) trial assessing Rybrevant in combination with carboplatin-pemetrexed compared to chemotherapy alone in patients with advanced or metastatic EGFR-mutated NSCLC and exon 20 insertion mutations; and the Phase I PALOMA (NCT04606381) study exploring the feasibility of subcutaneous administration based on safety and pharmacokinetics and to determine a dose regimen and formulation for Rybrevant SC delivery.

Rybrevant gained FDA accelerated approval in May 2021 as the first targeted treatment for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations. Rybrevant represents the first fully human, bispecific antibody approved in lung cancer. The simultaneous approval of a companion diagnostic aids in the identification of exon 20 insertion mutations, according to Janssen.

The oral, third-generation, brain-penetrant, EGFR tyrosine kinase inhibitor (TKI) lazertinib targets both the T790M mutation and activating EGFR mutations while sparing wild type-EGFR. Interim safety and efficacy results from the lazertinib Phase I-II trial were published in The Lancet Oncology during 2019. One year earlier, Janssen Biotech entered into a license and collaboration pact with Yuhan Corp. for the development of lazertinib.

Findings from the Xarelto (rivaroxaban) Phase III COMPASS Long-Term Open Label Extension (LTOLE) study and the Xarelto in Combination with Acetylsalicylic Acid (XATOA) registry were published in the European Society of Cardiology’s (ESC) European Heart Journal, Cardiovascular Pharmacotherapy. The XATOA registry also was presented at the American Congress of Cardiology’s 71st Annual Scientific Session. Johnson & Johnson said these studies provide further evidence supporting the role of dual pathway inhibition (DPI) with the Xarelto vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) in patients with coronary artery disease (CAD) and/or Peripheral Artery Disease (PAD).

The COMPASS open-label extension study results support the long-term use of Xarelto combined with aspirin for vascular protection in patients with chronic CAD and/or PAD. The XATOA registry provides additional evidence of the benefit of DPI for CAD and/or PAD patients at high risk of cardiovascular (CV) events.  

Xarelto has been prescribed more than 80 million times in the United States alone. The medicine works by slowing the body’s ability to clot by selectively blocking one of the clotting factors found in blood – an enzyme called Factor Xa (“10a”). The oral anticoagulant is intended for the prevention of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE) in patients undergoing hip or knee replacement surgery, to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and for treating and reducing of risk of recurrence of DVT and PE to reduce the risk of major cardiovascular events in patients with CAD and PAD, for the treatment and secondary prevention of thromboembolism in pediatric patients, and for thromboprophylaxis in pediatric patients following the Fontan procedure.

Medical device updates

Ethicon, part of Johnson & Johnson MedTech, during June 2022 announced the U.S. launch of the Echelon 3000 Stapler, a digitally enabled device that provides surgeons with simple, one-handed powered articulation to help address the unique needs of their patients. Designed with 39 percent greater jaw aperture and a 27 percent greater articulation span, Echelon 3000 provides surgeons with better access and control over every transection, even in tight spaces and on challenging tissue. According to Ethicon, these features combined with software that provides real-time haptic and audible device feedback enable surgeons to make critical adjustments during procedures.

Mentor MemoryGel Boost Breast Implant was cleared for marketing by the FDA in January 2022. According to Mentor Worldwide, the No. 1 global brand in breast aesthetics and part of the Johnson & Johnson Medical Devices Companies (JJMDC), the implant provides the natural feel patients desire with increased form stability to shape the breast. A study demonstrated that patients and surgeons preferred the Mentor MemoryGel Boost Breast Implant as feeling more like a natural breast versus another leading brand.  

In other January 2022 news, a collaboration was announced with Microsoft to further enable and expand JJMDC’s secure and compliant digital surgery ecosystem. Management said the Microsoft Cloud will help JJMDC realize its vision of driving innovation that advances skills, improves workflow, and enhances surgical decision making for a better overall
customer experience and improved patient and economic outcomes. 

Renewed Commitment to Fight NTDs

Johnson & Johnson during June 2022 joined the worldwide community, including governments, foundations, non-profit organizations, and other pharma companies, to endorse the Kigali Declaration on Neglected Tropical Diseases. Together, they are recommitting to their long-established efforts to control and eliminate neglected tropical diseases (NTDs), a set of debilitating diseases that put at risk the health of 1.7 billion people globally, especially the most vulnerable and underserved. J&J is dedicated to combat the neglect impacting three major public health challenges: intestinal worms (soil-transmitted helminths or STH), dengue, and leprosy.  

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