US FDA approves Eli Lilly's drug for eczema
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[September 14, 2024]
(Reuters) -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.
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.
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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.
(Reporting by Puyaan Singh in Bengaluru; Editing by Krishna Chandra
Eluri)
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