Pfizer's Abrocitinib Receives Positive CHMP Opinion For Atopic Dermatitis Treatment

The European Medicines Agency's or EMA Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending the 100 mg and 200 mg doses of abrocitinib, an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis or AD in adults who are candidates for systemic therapy, Pfizer Inc. (PFE) said in a statement on Friday.

Pfizer also said that the CHMP adopted a positive opinion recommending marketing authorization for XELJANZ (tofacitinib) 5 mg and 10 mg, administered twice daily, for the treatment of adults with active ankylosing spondylitis (AS) who have responded inadequately to conventional therapy.

Based on these 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.

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Sandoz, Inc., an unit of Novartis AG, is recalling one lot of deep vein thrombosis (DVT) medication Enoxaparin Sodium in the form of injection for the potential exposure to high temperatures that may have impacted product effectiveness, the U.S. Food and Drug Administration or FDA said in a statement. Livia Global, Inc., a health and wellness company, is recalling two lots of its Liviaone liquid probiotics citing the possibility of contamination by Pseudomonas aeruginosa, the U.S. Food and Drug Administration said. Pseudomonas aeruginosa is a microorganism found in the environment that, if ingested, can cause life-threatening infection in immunocompromised individuals. United Airlines operated Thursday the first ever passenger flight using 100% Sustainable Aviation Fuel or SAF as part of its efforts to combat climate change. The airline flew the green flight from Chicago's O'Hare International Airport or ORD to Washington, D.C.'s Reagan National Airport or DCA with more than 100 passengers.
Follow RTT