INDIANAPOLIS - Eli Lilly and Company (NYSE: NYSE:LLY) announced that its drug EBGLYSS, an interleukin-13 (IL-13) inhibitor, has shown to improve skin condition and reduce itchiness in patients with moderate-to-severe atopic dermatitis who had an inadequate response to the previously available treatment, dupilumab. These findings are based on the Phase 3b ADapt study and will be presented at the Fall Clinical Dermatology Conference.
The study's primary goal was to achieve at least 75 percent improvement in the Eczema Area and Severity Index (EASI-75) score at 16 weeks. Results indicated that 57 percent of patients at Week 16 and 60 percent at Week 24 met this endpoint. Notably, 53 percent and 62 percent of patients reported significant itch relief at the same intervals.
EBGLYSS was also effective in treating areas that are often difficult to manage, such as the face and hands. Over half of the participants saw clear or almost clear skin on their faces, and those with severe hand dermatitis experienced a 75 percent reduction in their modified total lesion symptom score at Week 24.
The safety profile of EBGLYSS was consistent with previous Phase 3 studies, with the majority of side effects being mild or moderate. Less than six percent of patients discontinued treatment due to adverse events. Notably, among patients who had stopped using dupilumab due to eye-related issues, facial dermatitis, or inflammatory arthritis, none reported similar events with EBGLYSS.
The U.S. Food and Drug Administration (FDA) approved EBGLYSS last month as a first-line biologic treatment for adults and children aged 12 and older with moderate-to-severe atopic dermatitis not well controlled with topical prescription therapies. The drug is administered initially as two 250 mg injections at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16. Upon achieving an adequate clinical response, patients then receive a single monthly maintenance injection.
EBGLYSS has also been approved in the European Union in 2023 and Japan in January 2024, with expectations for additional market approvals later this year. Eli Lilly holds exclusive rights for the drug's development and commercialization outside Europe, while Almirall S.A. has licensed rights within Europe.
These results, based on a press release statement, suggest EBGLYSS could be a beneficial treatment option for patients with moderate-to-severe atopic dermatitis, particularly those who have not responded well to other biologic treatments like dupilumab.
In other recent news, Eli Lilly has initiated legal action against three entities for allegedly selling counterfeit versions of its weight-loss drug Zepbound. The pharmaceutical firm's lawsuits target Pivotal Peptides, MangoRx, and Genesis Lifestyle Medicine of Nevada. Leerink Partners has maintained its Outperform rating on Eli Lilly shares, following news of a UK study to assess the impact of Eli Lilly's drug tirzepatide on the economic strain caused by obesity. Eli Lilly's mirikizumab, an investigational treatment for Crohn's disease, showed promising results in a recent study, achieving a higher rate of histologic response compared to ustekinumab after 52 weeks of treatment. The company is also involved in a legal dispute with the U.S. Food and Drug Administration and the Outsourcing Facilities Association over tirzepatide's supply status. Lastly, concerns have been raised about Novo Holdings' acquisition of Catalent (NYSE:CTLT) by U.S. Senator Elizabeth Warren and Eli Lilly, suggesting it could give Novo Nordisk (NYSE:NVO) an unfair competitive advantage in the market for weight loss and obesity medications. These are recent developments.
InvestingPro Insights
Eli Lilly's recent success with EBGLYSS aligns with the company's strong market position and financial performance. According to InvestingPro data, Eli Lilly boasts a substantial market capitalization of $802.57 billion, reflecting investor confidence in the company's growth potential. This is further supported by the company's impressive revenue growth of 31.87% over the last twelve months, with quarterly revenue growth reaching 35.98% in Q2 2024.
The pharmaceutical giant's focus on innovative treatments like EBGLYSS is likely contributing to its robust financial health. Eli Lilly's gross profit margin stands at an impressive 80.75%, indicating strong pricing power and efficient cost management in its product portfolio.
InvestingPro Tips highlight Eli Lilly's strength in the pharmaceutical industry. One tip notes that Eli Lilly is a "Prominent player in the Pharmaceuticals industry," which is evident from its successful development and approval of EBGLYSS. Another relevant tip mentions that "Net income is expected to grow this year," suggesting that the company's new treatments, including EBGLYSS, could contribute to improved financial performance.
It's worth noting that Eli Lilly has maintained dividend payments for 54 consecutive years, demonstrating long-term financial stability. This track record, combined with the company's recent product successes, may appeal to investors looking for both growth and income potential.
For readers interested in a deeper analysis, InvestingPro offers 17 additional tips for Eli Lilly, providing a comprehensive view of the company's financial health and market position.
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