With an FDA approval in atopic dermatitis for Ebglyss, Eli Lilly hopes to challenge Regeneron and Sanofi's Dupixent, which is dominant in the indication.
Three years after establishing an immunology unit, Eli Lilly has gained its third FDA approval in the specialty area as the U.S. regulator has signed off on IL-13 inhibitor Ebglyss to treat atopic dermatitis (AD).The endorsement covers adults and patients between the ages of 12 and 18 who weigh at least 88 pounds. It is for those who have a moderate-to-severe form of the disease and don't achieve an adequate response with prescription topical treatments. The company said it plans to launch Ebglyss, also known as lebrikizumab, in the coming weeks but is not yet divulging its price in the U.S.The nod comes on top of Lilly expanding its label for JAK inhibitor Olumiant in 2022 as the first systemic medicine to treat alopecia areata and gaining approval in October of last year for IL-23 ulcerative colitis therapy Omvoh. In 2022, Lilly’s then chief of its immunology unit, Patrik Jonsson, said that the company was making a “long-term commitment” to immunology for the “coming decade or decades.”As part of the push in 2020, Lilly acquired lebrikizumab when it bought out California-based Dermira for $1.1 billion.The approval for Ebglyss comes a year late. The FDA rejected it in October, citing findings from an inspection of a third-party manufacturer. The agency’s complete response letter (CRL) did not raise any issues with lebrikizumab’s clinical data package, label or safety.Earlier this year, Japan and Canada signed off on Ebglyss. It was approved last year in Europe, where Spain’s Almirall has licensed the rights to develop and commercialize it for dermatology indications. “Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives,” Jonathan Silverberg, M.D., Ph.D., professor of dermatology at George Washington University School of Medicine and Health Sciences, said in a release.Ebglyss is dosed monthly with a 250 mg injection after an introductory regimen, which includes 250 mg injections two weeks apart until adequate clinical response is achieved. It can be used along with topical corticosteroids. Three trials, which included more than 1,000 patients, backed the approval of Ebglyss. In the ADvocate 1 and 2 studies, an average of 38% of those who took Ebglyss had clear or almost-clear skin after 16 weeks, versus 12% on placebo. Of those who achieved that standard, 77% retained those results with maintenance dosing for a year. Of those Ebglyss responders who switched to placebo at Week 16, 48% maintained their results for a year.Lilly hopes to challenge Regeneron and Sanofi’s dominant IL-4/IL-13 treatment in the indication, Dupixent. Another IL-13 on the market for AD is Leo Pharma’s Adbry, which was launched in 2022.
