By Colin Kellaher

 

Pfizer Inc. on Friday said the European Commission approved its Cibinqo once-daily JAK inhibitor for adults with moderate-to-severe atopic dermatitis, the most common form of the inflammatory skin disease eczema.

The New York drugmaker said the commission approved 100- and 200-milligram doses of Cibinqo, a potential rival to the blockbuster eczema treatment Dupixent from Regeneron Pharmaceuticals Inc. and Sanofi SA, for adults who are candidates for systemic therapy.

The company said the commission also approved a 50-milligram dose for patients with moderate and severe renal kidney failure or certain patients receiving treatment with inhibitors of cytochrome P450 2C19.

Cibinqo, which received marketing approval in the U.K., Japan and Korea earlier this year, is under review by the U.S. Food and Drug Administration, which has delayed its decision and hasn't set a new target action date as the agency looks into the safety of JAK inhibitor drugs.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

December 10, 2021 10:04 ET (15:04 GMT)

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