usatoday.com
On Friday, the U.S. Food and Drug Administration approved Eli Lilly's eczema drug for use in adults and children 12 and older.
The medication is an injectable branded Ebglyss and 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.
Ebglyss is a monoclonal antibody that selectively targets and neutralizes the IL-13 protein that causes progression of eczema.
The FDA's approval 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," said Dr. Jonathan Silverberg, professor of dermatology at George Washington University School of Medicine and Health Sciences and first author on the study summarizing the clinical trials.
Last year, the regulator 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.