Atopic dermatitis is treatable with many drugs currently on the market, but many patients find these therapies lacking. The FDA has approved an Eli Lilly drug that offers a new biologic treatment option with a dosing schedule that’s less burdensome for patients.
The regulatory decision announced late Friday covers the treatment of adults and children age 12 and older with moderate-to-severe atopic dermatitis that is not well controlled with topical prescription drugs. The Lilly drug, lebrikizumab, will be marketed as Ebglyss, which is the same brand name for the product in Europe and Japan where it has already been approved.
The excessive immune response in atopic dermatitis, also known as eczema, leads to skin that’s dry, itchy, and inflamed. More than 16 million adults in the U.S. have eczema, and 6.6 million of these patients experience moderate-to-severe symptoms, according to the National Eczema Association. Topical steroids are a standard treatment, but many patients find these anti-inflammatory therapies do not sufficiently control symptoms. Lilly’s Ebglyss takes a different approach. The drug is an antibody designed to target and block IL-13, a signaling protein associated with the inflammation that drives atopic dermatitis. The injectable drug was initially developed by skin disease biotech Dermira, which Lilly acquired for $1.1 billion in 2020.
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Drugs that target IL-13 to treat atopic dermatitis are already available. This disease was the first indication for Sanofi and Regeneron Pharmaceuticals drug Dupixent, which won its first FDA approval in 2017. The biologic medicine has since become a blockbuster product with approvals in several autoimmune disorders (the FDA on Friday approved Dupixent for chronic rhinosinusitis with nasal polyps). Dupixent is an antibody engineered to block two signaling pathways, IL-13 and IL-14. LEO Pharma’s Adbry, an antibody designed to block IL-13, won FDA approval in atopic dermatitis in 2021. Dupixent and Adbry are administered as every-other week injections following initial dosing.
Lilly’s Ebglyss offers patients its IL-13-blocking effects with once-monthly maintenance dosing. FDA approval of Ebglyss is based on results from two Phase 3 studies that showed 38% of participants who received the study drug achieved clear or almost-clear skin at 16 weeks. By comparison, 12% of those in the placebo arm achieved that mark at 16 weeks. Of those who experienced clear or almost-clear skin at week 16, 77% maintained these results at one year with once-monthly dosing.
Study results also showed itch relief. On average, 43% of participants who took Ebglyss felt itch relief at 16 weeks compared to 12% of those who were given a placebo, Lilly said. Of those people who felt itch relief at week 16, 85% still felt that relief at one year with once-monthly maintenance dosing. The most common side effects reported in the studies included eye and eyelid inflammation, injection site reactions, and shingles. According to Jonathan Silverberg, professor of dermatology at George Washington University School of Medicine and Health Sciences and first author of the Ebglyss clinical trial results published last year in The New England Journal of Medicine, patients still struggle to control moderate-to-severe atopic dermatitis with currently available therapies.
“Today’s FDA approval of Ebglyss is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren’t enough,” Silverberg said in Lilly’s announcement of the drug’s approval.
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The FDA nod for Ebglyss comes later than Lilly initially expected. Last October, the FDA turned down Lilly’s submission for the drug citing problems with the product’s third-party manufacturer. No issues were raised about clinical data or safety. The European Commission approved Ebglyss last November. Barcelona-based Alimirall licensed European rights to Ebglyss; Lilly retains rights to the drug in the rest of the world. Regulators in Japan approved Ebglyss early this year. Lilly expects regulatory decisions for the drug in other markets later this year. The company said Ebglyss will become available in the U.S. in coming weeks.
Photo: Konrad Fiedler/Bloomberg, via Getty Images