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.
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