INDIANAPOLIS - The U.S. Food and Drug Administration approved a new maintenance dosing regimen for Eli Lilly and Company’s (NYSE:LLY) Ebglyss (lebrikizumab-lbkz), allowing one injection every eight weeks for adults and children 12 years and older weighing at least 88 pounds with moderate-to-severe atopic dermatitis, according to a press release statement issued today.The approval comes as Eli Lilly continues its strong market performance, with the pharmaceutical giant boasting a market capitalization of $1.02 trillion and revenue growth of 47% over the last twelve months. According to InvestingPro analysis, the company currently trades slightly above its Fair Value, though investors have enjoyed a 49% return over the past year.
The approval allows patients to manage their condition with as few as six maintenance injections per year. Ebglyss was previously approved for once-monthly maintenance dosing.
The recommended initial starting dose remains 500 mg at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or later when adequate clinical response is achieved. After this period, patients can choose maintenance dosing of 250 mg every four weeks or every eight weeks.
The approval is based on longitudinal exposure-response modeling data and supported by clinical data from an extension to the Phase 3 ADjoin long-term trial. The extension evaluated Ebglyss maintenance dosing every four weeks or every eight weeks over 32 weeks.
No new safety signals were noted in the 32-week ADjoin extension. No patients discontinued due to adverse events through 32 weeks. The most common adverse reactions reported with Ebglyss are conjunctivitis, injection site reactions and herpes zoster.
Ebglyss is a monoclonal antibody that selectively targets and neutralizes IL-13. The drug can be administered with or without topical corticosteroids for patients whose condition is not well-controlled with topical prescription therapies.
Lilly holds exclusive rights for development and commercialization of Ebglyss in the U.S. and outside Europe. Almirall has licensed the rights to develop and commercialize the drug for dermatology indications in Europe.For deeper insights into Eli Lilly’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available for this and 1,400+ other US equities on InvestingPro.
Ebglyss was approved in the U.S., Japan and Canada in 2024 and in the European Union in 2023.
In other recent news, Eli Lilly has presented promising data from its phase 3 trials for the obesity and diabetes drug Retatrutide. The TRIUMPH-1 and TRANSCEND-1 trials showed that the 4mg dose of the drug achieved a 17% weight loss, while the 12mg dose resulted in approximately 30% weight loss, with adverse events comparable to placebo. Following these results, Bernstein SocGen Group reiterated an Outperform rating for Eli Lilly, maintaining a price target of $1,300. Truist Securities also reaffirmed a Buy rating, citing the drug’s best-in-class weight loss efficacy at the lower dose. Additionally, Morgan Stanley reiterated an Overweight rating, with a price target of $1,344, noting a potential 7% upside for the company’s Mounjaro and Zepbound products by 2026. The American Diabetes Association conference highlighted Eli Lilly’s efforts to solidify its market leadership in obesity and type 2 diabetes treatments. These developments come as oral GLP-1 therapies for obesity are gaining early traction in the U.S. market, although current usage remains modest.
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