Pfizer Gets Positive CHMP Opinion for Abrocitinib in Atopic Dermatitis

By Michael Dabaie

Pfizer Inc. said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended the 100 mg and 200 mg doses of abrocitinib for marketing authorization to treat moderate to severe atopic dermatitis in adults.

The CHMP also gave a positive opinion recommending marketing authorization for Xeljanz 5 mg and 10 mg, administered twice daily, for the treatment of adults with chronic, inflammatory disease ankylosing spondylitis.

Based on the CHMP recommendations, a decision by the European Commission, which authorizes marketing approval in the European Union, is expected on the abrocitinib and Xeljanz applications later this year, Pfizer said.

If granted by the European Commission, the centralized marketing authorizations would be valid in all EU Member states as well as in Iceland, Liechtenstein, and Norway.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

October 15, 2021 08:23 ET (12:23 GMT)

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