Pfizer receives ‘positive’ CHMP opinion for alopecia areata treatment

Pfizer announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for LITFULO, an oral treatment, recommending marketing authorization of once-daily 50 mg for individuals 12 years of age and older with severe alopecia areata. The European Commission, which authorizes central marketing approvals in the European Union (EU), will take a legally binding decision based on the CHMP recommendation and is expected to make a final decision in the coming months. If granted, the centralized marketing authorization of LITFULO would be valid in all 27 EU member states, as well as in Iceland, Liechtenstein, and Norway. LITFULO, if approved, would be the only treatment authorized for patients as young as 12 years of age with severe alopecia areata in this market. “Alopecia areata is an autoimmune disease and the burden of hair loss can negatively impact patients’ day-to-day lives,” said Aida Habtezion, Senior Vice President, Chief Medical Officer and Head of Worldwide Medical and Safety, Pfizer Inc. “This positive CHMP recommendation for LITFULO brings us one step closer to providing a once-daily treatment for patients as young as 12 years of age in the EU who are living with the challenges of severe alopecia areata.”