Sept 13 (Askume) – Eli Lilly and Co LLY.N said on Friday the U.S. Food and Drug Administration has approved its eczema drug for use in adults and children over 12 years of age.
The drug, an injectable medication branded as AbGliss, will be available in the coming weeks, the company said.
Eczema, also known as atopic dermatitis, is an inflammatory skin condition that causes itching, rashes, and dry patches.
Eli Lilly said the FDA approval was based on three studies that included more than 1,000 patients with moderate to severe eczema whose symptoms could not be controlled with topical medications or other systemic treatments.
Regulators refused to approve the drug last year after some problems were found during an inspection of the contract manufacturer .
According to the National Eczema Association, about 16.5 million adults in the United States have eczema.
There are a variety of treatments for eczema, including AbbVie’s (ABBV.N) Rinvoq, Pfizer’s (PFE.N) Sibinco, Sanofi’s (SASY.PA) and Regeneron’s (REGN.O) Dupixent, as well as some generics such as Sibinco’s Tirizine.
Unlike Dupixent, which adults must take twice a month, Abglis can be taken once a month, “which experts say both doctors and patients find attractive,” Jefferies analyst Lucy Coddington wrote in a report last year.
The drug has already been approved for use in Europe and Japan, and is expected to enter more markets later this year, the company said.
AbGlyce is a monoclonal antibody that selectively targets and inactivates the IL-13 protein that contributes to the progression of eczema.
