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Cibinqo recommended for approval by CHMP for atopic dermatitis – Pfizer
Pfizer announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the 100 mg and 200 mg doses of Cibinqo (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for marketing authorization to treat moderate to severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.
The recommendation for abrocitinib is based on the results of five Phase III studies and a long-term extension study from a robust clinical trial program including more than 3,100 patients.