For all its forays elsewhere, diabetes remains the bedrock of Lilly’s business – and, if the Mounjaro launch goes as hoped, will continue to be so for a long time to come.

By Joshua Slatko • josh.slatko@medadnews.com

Eli Lilly

Lilly Corporate Center

Indianapolis, IN 46285

317-276-2000 • lilly.com

Best-selling products

All sales are in millions of dollars.

2021 sales

• Trulicity $6,472 
• Humalog $2,453 
• COVID-19 antibodies $2,239 
• Taltz $2,213 
• Alimta $2,061 
• Jardiance $1,491 
• Verzenio $1,350 
• Humulin $1,223 
• Olumiant $1,115 
• Cyramza $1,033 
• Basaglar $893 
• Forteo $802 
• Cialis $718 
• Cymbalta $582 
• Emgality $577 
• Erbitux $548

1H 2022 sales

• Trulicity $3,653 
• COVID-19 antibodies $1,599 
• Taltz $1,094 
• Humalog $1,065 
• Verzenio $1,058 
• Jardiance $880 
• Alimta $572 
• Humulin $547 
• Cyramza $462 
• Olumiant $442 
• Basaglar $366 
• Cialis $365 
• Emgality $307 
• Forteo $276 
• Erbitux $263

Outcomes Creativity Index Score: 7

• Manny Awards — 2
• Cannes Lions — N/A
• Clio Health — N/A
• Creative Floor Awards — 2
• London International Awards – 2
• MM+M Awards — N/A
• One Show — 1

Chair and CEO David A. Ricks

The diabetes focus just keeps paying dividends for Lilly. While the company has expanded the scope of its portfolio beyond its traditional specialty in recent years with successful products such as Taltz (autoimmune), Verzenio (breast cancer), and Olumiant (autoimmune and COVID), Lilly’s biggest seller (Trulicity), one of its fastest growers (Jardiance), and the company’s most promising new launch (Mounjaro) all target diabetes. Lilly’s diabetes treatments still account for nearly half of the company’s total revenue – and perhaps more, soon, if Mounjaro performs as hoped. 

“We had an exciting quarter with the highly anticipated U.S. launch of Mounjaro, the first of potentially five new medicines we intend to launch by the end of 2023,” said David A. Ricks, Lilly’s chair and CEO, in the Q2 2022 earnings announcement. “We are pleased with the underlying strength of our core business, and we expect our new medicines will add to our growth through the rest of the decade. We are entering a compelling era in our company’s history, as we continue our efforts to expand the number of people our medicines can help.”

Lilly’s top-line revenue was $28.32 billion in 2021, up 15.4 percent compared with the previous year. Net income declined by 9.9 percent to $5.58 billion, and earnings per share were down 67 cents to $6.12. In the first half of 2022 Lilly’s top line rose another 5.6 percent to $14.3 billion, with net income up 4 percent to $2.86 billion and EPS rising 15 cents to $3.16. Company leaders project that full-year EPS for 2022 will fall between $6.96 and $7.11. 

Acquisitions and partnerships

In January, Lilly acquired exclusive rights to Entos Pharmaceuticals’ Fusogenix nucleic acid delivery technology to research, develop, and commercialize nucleic acid products targeting the central and peripheral nervous system. This technology, company leaders say, provides an opportunity for Lilly to access a novel delivery platform technology with the potential to solve a key delivery challenge for many nucleic acid therapeutic modalities.

Under the terms of the research and collaboration agreement, Lilly and Entos agreed to multiple programs focused on the development of proteo-lipid vehicles (PLV) for delivery of therapeutic cargo supplied by Lilly to targets in the central and peripheral nervous systems. Entos is responsible for the generation, development, and optimization of PLVs using its proprietary Fusogenix platform technology. Lilly is responsible for selecting PLVs for clinical development and commercialization. Entos received an initial payment of $50 million, which included an equity investment by Lilly in Entos. For each of the programs under the collaboration, Entos is also eligible to receive up to $400 million in potential developmental and commercial milestone payments, as well as royalties upon the successful development and commercialization of products.

Product performance

Sales of Trulicity grew by more than a quarter in 2021, to $6.47 billion.

The type 2 diabetes treatment Trulicity remained at the top of Lilly’s portfolio in 2021, enjoying a sales bounce of 27.7 percent to $6.47 billion for the year. According to company leaders, this was due to increased demand in the United States and increased volume internationally. In the first half of 2022, sales of Trulicity rose another 22.3 percent to $3.65 billion.

In June, Lilly announced results from the Phase III AWARD-PEDS clinical trial showing that Trulicity (at 0.75 mg and 1.5 mg doses) led to superior A1C reductions at 26 weeks versus placebo in youth and adolescents (ages 10 to 17 years old) with type 2 diabetes inadequately controlled with diet and exercise, with or without metformin and/or basal insulin. The study met all of its primary and secondary glycemic control objectives: percent of patients achieving A1C of <7%, fasting plasma glucose change from baseline, and mean change in A1C in the individual dose groups. Significant reductions in both A1C and fasting glucose were observed through week 26 compared to placebo. Among patients treated with Trulicity (pooled data), 51.5 percent reached an A1C of <7% based on treatment regimen estimand.

The AWARD-PEDS trial evaluated the efficacy and safety of once-weekly Trulicity 0.75 mg and 1.5 mg compared to placebo in youth and adolescents with type 2 diabetes inadequately controlled with diet and exercise, with or without metformin and/or basal insulin. Study participants included 55 percent identifying as Hispanic/Latino and 15 percent as Black/African American, with a mean age of 14.5 years and a mean body mass index of 34.1 kg/m². The mean duration of diabetes was 2.0 years, mean A1C was 8.1 percent, and mean weight was 90.5 kg. The primary objective was to demonstrate superiority of Trulicity (pooled dose groups) versus placebo for change from baseline in A1C at 26 weeks. The study achieved this primary objective, and both doses of Trulicity (0.75 mg and 1.5 mg) achieved superior and statistically significant A1C reductions from baseline compared to placebo and also achieved significant results for key secondary endpoints of glycemic control at 26 weeks. 

Humalog, an injectable human insulin analog for treating diabetes, generated $2.45 billion in sales for Lilly in 2021, a decline of 6.6 percent. Company leaders say this was driven by lower realized prices in the United States due to higher contracted rebates and discounts and increased utilization in more highly rebated government segments. In the first half of 2022, sales of Humalog fell another 13.1 percent to $1.07 billion.

Sales of Lilly’s COVID-19 antibodies bamlanivimab and etesevimab, treatments for mild to moderate COVID-19 for higher-risk patients and for post-exposure prophylaxis in certain individuals for the prevention of SARS-CoV-2 infection, totaled $2.24 billion in 2021, more than double their 2020 figure of $871 million. First-half 2022 sales of the COVID-19 antibodies rose 66.7 percent to $1.6 billion.

The autoimmune drug Taltz generated $2.21 billion in sales for Lilly in 2021, an improvement of 23.7 percent. Company leaders credited this to increased demand domestically and increased volume internationally. In the first half of 2022, sales of Taltz were up another 12.6 percent to $1.09 billion.

In August, Lilly announced the availability of a new, citrate-free formulation of Taltz injection 80 mg/mL. The new formulation, approved by the FDA in May 2022, includes the same active ingredient as the original version. The new Taltz formulation significantly reduced injection site pain experienced by some people immediately following injection as shown by an 86 percent decrease in a visual analog scale of pain versus the original form.

Jardiance enjoyed growth of more than 30 percent during first-half 2022, helped along by a new heart failure approval from the FDA.

The type 2 diabetes drug Jardiance brought in sales of $1.49 billion for Lilly in 2021, 29.2 percent better than the previous year. According to company leaders, this was due to increased demand in the United States and increased volume internationally. In the first half of 2022, Jardiance sales rose 31.5 percent to $880 million.

In February, the FDA approved Jardiance 10 mg to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. This approval was based on results from the landmark EMPEROR-Preserved Phase III trial, which investigated the effect of Jardiance 10 mg compared with placebo once daily, both on top of standard of care therapy, in 5,988 adults with heart failure with LVEF over 40 percent. In the trial, Jardiance demonstrated a 21 percent relative risk reduction (3.3 percent absolute risk reduction) for the composite primary endpoint of cardiovascular death or hospitalization for heart failure. In both EMPEROR-Preserved and EMPEROR-Reduced, the benefit was generally consistent across LVEF subgroups. A key secondary endpoint analysis from EMPEROR-Preserved showed that Jardiance reduced the relative risk of first and recurrent hospitalizations for heart failure by 27 percent.

In March, Lilly and Boehringer Ingelheim announced that the EMPA-KIDNEY trial, evaluating the effect of Jardiance in adults with chronic kidney disease, would stop early based on a recommendation from the trial’s Independent Data Monitoring Committee. This followed a formal interim assessment that met prespecified criteria for positive efficacy. As the largest SGLT2 inhibitor trial in CKD to date, EMPA-KIDNEY evaluated the efficacy and safety of Jardiance in adults with CKD who are frequently seen in clinical practice but who have been under-represented in previous SGLT2 inhibitor trials, therefore addressing a critical unmet need. The trial included people with mildly to severely reduced eGFR (a measure of kidney function); with normal and increased levels of albumin (a type of protein present in the urine); with and without diabetes; and with CKD attributable to a wide range of underlying causes. Detailed trial results were expected in 2022.

Also in March, Lilly and Boehringer Ingelheim announced that adults hospitalized for acute heart failure were 36 percent more likely to experience a clinical benefit over 90 days if initiated on Jardiance following stabilization and prior to discharge compared with placebo in the Phase III EMPULSE trial. Clinical benefit reflected a composite primary endpoint that included all-cause mortality, frequency of heart failure events, time to first heart failure event, and symptoms as measured by the Kansas City Cardiomyopathy Questionnaire total symptom score (KCCQ-TSS). The overall clinical benefit with Jardiance was consistent for those with either new or pre-existing heart failure, for those with or without diabetes and for those with either preserved or reduced ejection fraction. In an exploratory secondary endpoint, Jardiance significantly improved KCCQ-TSS from baseline to day 90 by 4.5 points versus placebo.

In June, Lilly and Boehringer Ingelheim announced that two analyses of the final U.S. data from the EMPagliflozin compaRative effectIveness and SafEty (EMPRISE) real-world study showed Jardiance was associated with a reduction in risk of hospitalization for heart failure versus two other classes of glucose-lowering therapies in adults with type 2 diabetes in routine care. Relative risk reductions were 50 percent versus dipeptidyl peptidase-4 (DPP-4) inhibitors and 30 percent versus glucagon-like peptide 1 (GLP-1) receptor agonists.

Compared with DPP-4 inhibitors, Jardiance was also associated with a 40 percent reduction in relative risk of all-cause mortality in people who had Medicare. In the overall EMPRISE population, Jardiance was associated with a 12 percent reduction in the risk of the composite outcome of myocardial infarction or stroke compared with DPP-4 inhibitors. Compared with GLP-1 receptor agonists, Jardiance was associated with similar risks of heart attack, stroke, and all-cause mortality. All results for Jardiance compared with GLP-1 receptor agonists, and with liraglutide (a GLP-1 receptor agonist) specifically, were consistent for people with and without cardiovascular disease.

Results from the EMPRISE real-world study, which assessed the first five years of use of Jardiance in the United States, complement previously reported data from the landmark EMPA-REG OUTCOME trial, in which Jardiance showed a 35 percent relative risk reduction in hospitalization for heart failure compared with placebo in adults with type 2 diabetes and established cardiovascular disease. EMPA-REG OUTCOME also showed a 38 percent relative risk reduction in cardiovascular death with Jardiance versus placebo.

Verzenio, a treatment for HR+, HER2- metastatic breast cancer and high-risk early breast cancer, produced $1.35 billion in sales in 2021, up 47.9 percent compared with the previous year. This, Lilly executives say, was driven by increased demand domestically and increased volume internationally. In the first half of 2022, Verzenio sales were up another 73.4 percent to $1.06 billion.

Helped along by use for treatment of COVID-19, sales of Olumiant nearly doubled in 2021 to $1.12 billion.

The autoimmune product Olumiant earned $1.12 billion in sales in 2021, nearly double its previous total of $639 million. This was driven in part by the use of Olumiant for the treatment of hospitalized patients with COVID-19. First-half 2022 sales of Olumiant rose another 10 percent to $442 million.

In January, Lilly announced that the company had decided to discontinue Phase III development of Olumiant in lupus based on top-line efficacy results from two pivotal Phase III trials (SLE-BRAVE-I and II). In SLE-BRAVE-I, the Olumiant 4-mg oral dose met the primary endpoint, demonstrating a statistically significant reduction in disease activity as measured by the proportion of adults with active lupus who achieved an SRI-4 response (a composite measurement of overall disease activity) at Week 52 compared to placebo. The SLE-BRAVE-II study, which also studied adults with active lupus, did not meet the primary endpoint of SRI-4 response. Key secondary endpoints were not met in either study.

At the same time, Lilly announced that the company was in ongoing discussion with the FDA regarding the status of the sNDA for Olumiant for the treatment of adults with moderate-to-severe atopic dermatitis. According to executives, the company did not have alignment with the FDA on the indicated population. Given the agency’s position, company leaders suggested a possibility that this could lead to a complete response letter. The efficacy and safety profile of Olumiant was evaluated in eight atopic dermatitis clinical trials (six double-blind, randomized, placebo-controlled studies and two long-term extension studies) inclusive of patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The safety profile in these trials was consistent with previously published Olumiant data.

In May, the FDA approved Olumiant for the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation with a recommended dose of 4-mg once daily for 14 days or until hospital discharge, whichever comes first. FDA’s approval was supported by results from two randomized, double-blind, placebo-controlled Phase III studies (ACTT-2 and COV-BARRIER, including the COV-BARRIER OS 7 addendum study). Olumiant has been available in the United States under Emergency Use Authorization for this indication since November 2020.

In June, the FDA approved Olumiant as a first-in-disease systemic treatment for adults with severe alopecia areata, available as 4-mg, 2-mg and 1-mg tablets. The recommended dose is Olumiant 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. The approval was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 trials, the largest Phase III AA clinical trial program completed to date, evaluating the efficacy and safety of Olumiant in 1,200 adult patients with severe AA (≥50 percent scalp hair loss as defined by a Severity of Alopecia Tool [SALT] score ≥50). Across the studies at 36 weeks, 17-22 percent of patients taking Olumiant 2-mg/day and 32-35 percent of patients taking Olumiant 4-mg/day achieved 80 percent or more scalp hair coverage, compared to 3-5 percent taking placebo. Additionally, 11-13 percent of patients taking Olumiant 2-mg/day and 24-26 percent of patients taking Olumiant 4-mg/day achieved 90 percent or more hair coverage, compared to 1-4 percent of patients taking placebo; results for Olumiant 2-mg/day were not statistically significant under the multiplicity control plan for BRAVE-AA2. Among patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking Olumiant 4-mg daily at 36 weeks.

In the pipeline

In February, the FDA issued an Emergency Use Authorization for bebtelovimab, an antibody that demonstrates neutralization against the Omicron variant of COVID-19. Bebtelovimab can now be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. Concurrently with FDA’s action, Lilly announced an agreement with the U.S. government to supply up to 600,000 doses of bebtelovimab for $720 million. 

The data supporting this EUA were primarily based on analyses from the Phase II BLAZE-4 trial (NCT04634409), treatment arms 9-14. This trial was a Phase II, randomized, clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19 who were treated with the authorized dose of bebtelovimab (175 mg) alone or together with 700 mg bamlanivimab and 1,400 mg of etesevimab. Pseudovirus and authentic virus testing have demonstrated that bebtelovimab retains full neutralizing activity against Omicron. In addition, pseudovirus testing with bebtelovimab demonstrated that it retains neutralization against all other known variants of interest and concern, including BA.2.

Also in February, Lilly announced that patients with moderately to severely active ulcerative colitis who took mirikizumab achieved statistically superior rates of clinical remission at 12 weeks compared to patients taking placebo in the pivotal LUCENT-1 Phase III study. Patients who took mirikizumab also achieved statistically significant improvements across key secondary endpoints including clinical, symptomatic, endoscopic, and histologic (cellular level of tissue) measures, compared to those taking placebo.

This global study of 1,162 patients included patients who had never tried a biologic treatment (biologic-naïve) and harder-to-treat patients who had previously taken a biologic that failed. One in four patients treated with mirikizumab (24.2 percent) achieved the primary endpoint of clinical remission at 12 weeks, compared to one in seven on placebo (13.3 percent), indicating improved symptom relief and resolution or near resolution of inflammation. Nearly two-thirds of patients taking mirikizumab (63.5 percent) achieved clinical response, compared to less than half of patients treated with placebo (42.2 percent). 

Nearly half of patients taking mirikizumab (45.5 percent) achieved symptomatic remission at 12 weeks, compared to less than a third of patients taking placebo (27.9 percent). In as early as four weeks, more than one in five patients who took mirikizumab (21.8 percent) experienced a rapid improvement in their symptoms, compared to one in eight patients taking placebo (12.9 percent).

In as early as two weeks and sustained through 12 weeks, patients treated with mirikizumab had a statistically significant reduction on an 11-point bowel urgency severity scale. At 12 weeks, patients had an average reduction of 2.59 (2.32 to 2.85) points, compared to an average reduction of 1.63 (1.18 to 2.09) points for patients on placebo (p<0.00001). The 2-week bowel urgency endpoint was pre-defined but was not multiplicity-controlled.

In March, Lilly received a complete response letter from the FDA regarding the biologics license application for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of people with nonsquamous non-small cell lung cancer. The letter indicated that the review cycle was complete but that FDA was unable to approve the application in its current form, consistent with the outcome of the Oncologic Drugs Advisory Committee Meeting in February. The CRL included a recommendation for an additional clinical study, specifically a multiregional clinical trial comparing standard of care therapy for first-line metastatic NSCLC to sintilimab with chemotherapy utilizing a non-inferiority design with an overall survival endpoint. Lilly and partner developer Innovent Biologics Inc. are assessing next steps for the sintilimab program in the United States. 

In April, Lilly announced updated data from the Phase I/II LIBRETTO-001 trial of Retevmo in patients with RET fusion-positive non-small cell lung cancer. Among 247 patients previously treated with platinum chemotherapy, the confirmed objective response rate was 61.1 percent and among 69 treatment-naïve patients, the confirmed ORR was 84.1 percent. Twenty-six patients had measurable central nervous system metastases at baseline and treatment with Retevmo resulted in a CNS ORR of 84.6 percent, with 22 patients having a confirmed best response of complete response or partial response.

At a median follow-up of approximately two years in both the treatment-naïve and platinum-chemotherapy pretreated populations, median duration of response was estimated at 20.2 (55.2 percent censoring rate; 20.3 months median duration of follow-up) and 28.6 (60.9 percent censoring rate; 21.2 months median duration of follow-up) months, respectively and median progression free survival is estimated at 22.0 (53.6 percent censoring rate; 21.9 months median duration of follow-up) and 24.9 (55.9 percent censoring rate; 24.7 months median duration of follow-up) months, respectively. Of the 26 patients with measurable CNS disease, Retevmo treatment resulted in a median intracranial PFS of 19.4 months.

Also in April, Lilly announced that, at 16 weeks, 70 percent of patients with moderate-to-severe atopic dermatitis receiving lebrikizumab combined with standard-of-care topical corticosteroids (TCS) achieved at least 75 percent improvement in overall disease severity (EASI-75) in the Phase III ADhere trial. Among patients taking lebrikizumab plus TCS, 41 percent achieved clear or almost clear skin (IGA) at 16 weeks compared to 22 percent of patients taking placebo plus TCS. At 16 weeks, 70 percent of patients taking lebrikizumab plus TCS achieved an EASI-75 response compared to 42 percent taking placebo plus TCS. Differences between patients receiving lebrikizumab in combination with TCS and placebo with TCS were observed as early as four weeks for EASI-75.

Patients treated with lebrikizumab plus TCS also achieved statistically significant improvements across key secondary endpoints including skin clearance and itching, interference of itch on sleep, and quality of life measures, compared to placebo with TCS. Clinically meaningful differences were observed as early as four weeks for itch, interference of itch on sleep, and quality of life measures.

In May, the FDA approved Mounjaro injection, Lilly’s once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval was based on results from the Phase III SURPASS program, which included active comparators of injectable semaglutide 1 mg, insulin glargine, and insulin degludec. Efficacy was evaluated for Mounjaro 5 mg, 10 mg, and 15 mg used alone or in combination with commonly prescribed diabetes medications, including metformin, SGLT2 inhibitors, sulfonylureas, and insulin glargine. Participants in the SURPASS program achieved average A1C reductions between 1.8 percent and 2.1 percent for Mounjaro 5 mg and between 1.7 percent and 2.4 percent for both Mounjaro 10 mg and Mounjaro 15 mg. While not indicated for weight loss, mean change in body weight was a key secondary endpoint in all SURPASS studies. Participants treated with Mounjaro lost between 12 lb. (5 kg) and 25 lb. (11 kg) on average.

Also in May, Lilly announced results of the Phase III LUCENT-2 study showing that patients with ulcerative colitis who responded to mirikizumab at 12 weeks achieved and maintained statistically superior and clinically meaningful improvements at one year compared to placebo across the primary endpoint of clinical remission and all key secondary endpoints, including bowel urgency severity, using a novel, patient-reported outcome measure. Lilly submitted regulatory applications for mirikizumab in UC to the FDA and the European Medicines Agency in the first quarter of 2022; regulatory decisions are expected next year. 

Mirikizumab was superior to placebo on clinical, symptomatic, endoscopic, and histologic endpoints regardless of previous failure to TNF inhibitors, tofacitinib, or other biologics. Among patients who had responded to 12-week induction treatment with mirikizumab, one-half of patients receiving mirikizumab maintenance treatment (49.9 percent) achieved clinical remission at one year compared to one-fourth of patients on placebo (25.1 percent). Nearly two-thirds of patients receiving mirikizumab who achieved clinical remission at 12 weeks maintained clinical remission at one year (63.6 percent) compared to one-third of patients on placebo (36.9 percent). Nearly all patients receiving mirikizumab who achieved clinical remission at one year were not taking corticosteroids for at least three months prior to the end of maintenance treatment (97.8 percent).

A patient-centric, 11-point scale developed by Lilly was used to assess changes in bowel urgency severity. Among patients who achieved clinical response in the 12-week induction study and who had a baseline urgency severity of 3 or greater, more than two in five patients on mirikizumab (42.9 percent) achieved resolution or near resolution of bowel urgency severity at one year compared to one in four on placebo (25 percent). Among patients who achieved clinical response in the 12-week induction study, patients receiving mirikizumab had a statistically significant average reduction in bowel urgency severity of 3.80 (3.53 to 4.07) at one year, compared to 2.74 (2.35 to 3.14) points for patients on placebo. 

In June, the New England Journal of Medicine published detailed results from Lilly’s Phase III SURMOUNT-1 clinical trial evaluating Mounjaro for the treatment of obesity or overweight. Mounjaro met both co-primary endpoints of superior mean percent change in body weight from baseline and greater percentage of participants achieving body weight reductions of at least 5 percent compared to placebo for both estimands.

For the efficacy estimand, participants taking Mounjaro achieved average weight reductions of 16.0 percent (35 lb. or 16 kg on 5 mg), 21.4 percent (49 lb. or 22 kg on 10 mg) and 22.5 percent (52 lb. or 24 kg on 15 mg), compared to placebo (2.4 percent, 5 lb. or 2 kg). Additionally, 89 percent (5 mg) and 96 percent (10 mg and 15 mg) of people taking Mounjaro achieved at least 5 percent body weight reductions compared to 28 percent of those taking placebo.

Also in June, Lilly reported new data from a mechanism of action study and new analyses of the global registration program for Mounjaro. The mechanism of action study was a 28-week, randomized, double-blind, parallel study to evaluate the effect of Mounjaro 15 mg compared to placebo and to injectable semaglutide 1 mg. The primary endpoint compared the effect of Mounjaro 15 mg versus placebo on total clamp disposition index at 28 weeks. The secondary objectives compared the effects of Mounjaro 15 mg to placebo and to injectable semaglutide 1 mg on energy intake, appetite, and body composition in adults with type 2 diabetes as measured by change from baseline.

At 28 weeks, participants taking Mounjaro had significantly greater reductions in weight and in fat mass compared to those taking injectable semaglutide 1 mg and placebo. Weight reduction in the study was 11.2 kg (24.7 lb., Mounjaro 15 mg), 6.9 kg (15.2 lb., injectable semaglutide 1 mg) and 0 kg (placebo). Fat mass reduction was 9.7 kg (21.4 lb., Mounjaro 15 mg) and 5.9 kg (13.0 lb., injectable semaglutide 1 mg). Further, treatment with Mounjaro 15 mg and injectable semaglutide 1 mg resulted in significant reductions from baseline in energy intake (-348.4 kcal and -284.1 kcal, respectively) as well as reductions in appetite ratings.

Lilly also reported a post-hoc analysis of all five studies within the SURPASS global registration program. This analysis assessed the relationship between A1C and body weight reductions with Mounjaro treatment (5 mg, 10 mg, or 15 mg) across the SURPASS-1 through -5 clinical trials. Results showed that between 87 percent and 97 percent of participants taking Mounjaro experienced both A1C and weight reductions.

Additionally, the company announced results from an exploratory analysis of SURPASS-2 and SURPASS-3 evaluating the median time taken to achieve certain glycemic targets (i.e., median time to A1C <7% and ≤6.5%) and the median time taken to achieve at least 5% weight loss. The analysis compared the time to reach the A1C targets from baseline among participants treated with Mounjaro (5 mg, 10 mg, and 15 mg) versus those treated with injectable semaglutide 1 mg (SURPASS-2) or those treated with titrated insulin degludec (SURPASS-3), and the time to reach the weight target among participants treated with Mounjaro or injectable semaglutide 1 mg. Participants taking all three doses of Mounjaro reached these A1C targets about four weeks sooner than those taking injectable semaglutide 1 mg, and between four weeks and 12 weeks sooner than those taking titrated insulin degludec.

Specifically, results showed median time to achieve A1C <7%: 8 weeks (Mounjaro), 12 weeks (injectable semaglutide 1 mg), 12 weeks (titrated insulin degludec). Median time to achieve A1C ≤6.5% was 12 weeks (Mounjaro), 16 weeks (injectable semaglutide 1 mg), 24 weeks (titrated insulin degludec). And median time to achieve ≥5% weight reduction was 12 weeks (Mounjaro 10 mg and 15 mg), 16 weeks (Mounjaro 5 mg), 24 weeks (injectable semaglutide 1 mg).

Also in June, Lilly announced topline results from one-year analyses of the efficacy and safety of lebrikizumab, the company’s investigational IL-13 inhibitor for the treatment of patients with moderate-to-severe atopic dermatitis. The new findings from the Phase III clinical trials (ADvocate 1 and 2) showed eight out of ten patients who achieved clinical response (EASI-75) with lebrikizumab monotherapy at 16 weeks maintained skin clearance at one year of treatment with the once every two weeks or four weeks regimen. Additionally, patients treated with lebrikizumab maintained itch relief across the two trials over the one-year period.

In ADvocate 1, 79 percent of patients who received lebrikizumab every four weeks and 79 percent of patients who received lebrikizumab every two weeks maintained 75 percent or greater skin improvement (EASI-75) at one year of treatment. Additionally, 85 percent of patients who received lebrikizumab every four weeks and 77 percent of patients who received lebrikizumab every two weeks maintained EASI-75 response in ADvocate 2 at one year of treatment. 

In September, Lilly released detailed results from its Phase III monotherapy studies in atopic dermatitis showing that investigational lebrikizumab provided robust and durable improvements in skin clearance and itch for patients who achieved a clinical response at Week 16 through one year of treatment. Lebrikizumab, a high-affinity and potent IL-13 inhibitor, delivered similar results when dosed once every four weeks or once every two weeks after Week 16. Efficacy with every four week dosing, after a 16-week induction period with lebrikizumab every two weeks, was similar to that of every two week dosing. 

Lilly and partner developer Almirall SA planned to submit regulatory applications for lebrikizumab to the FDA and the European Medicines Agency during 2022.

Read More