US FDA nod to Eli Lilly's Eczema drug Ebglyss
Bengaluru: Eli Lilly said on Friday the U.S. Food and Drug Administration approved its eczema drug for use in adults and children above 12 years old.
The drug, which is an injectable medicine and branded Ebglyss, will be available in the next few weeks, the company said.
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Eczema, also known as atopic dermatitis, is an inflammatory skin condition that can cause itching, rashes and dry patches.
The FDA's approval was based on three studies involving over 1,000 patients with moderate-to-severe eczema who were unable to control their symptoms with topical medicines or other systemic treatments, Eli Lilly said.
Last year, the regulator had declined to approve the drug due to certain findings during an inspection of a contract manufacturer.
Nearly 16.5 million adults in the U.S. have eczema, according to the National Eczema Association.
Eczema has multiple treatments available, including AbbVie's Rinvoq, Pfizer's Cibinqo, Sanofi and Regeneron's Dupixent as well as some generic drugs such as cetirizine.
Unlike Dupixent, which has to be dosed twice a month for adults, Ebglyss can be dosed once-monthly, which is "viewed as attractive by experts and likely also patients," Jefferies analyst Lucy Codrington wrote in a note last year.
The drug is already approved for use in Europe and Japan, with additional markets expected later this year, the company said.
Ebglyss is a monoclonal antibody that selectively targets and neutralizes the IL-13 protein that causes progression of eczema.
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