CHMP recommends approval of Besremi for polycythaemia vera.- PharmaEssentia.
PharmaEssentia announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Besremi (ropeginterferon alfa-2b), intended for the treatment of polycythaemia vera without symptomatic splenomegaly.
The positive CHMP opinion is based on the comprehensive data package from the PROUD-PV/CONTINUATION-PV clinical development program, which was sponsored by AOP Orphan. PharmaEssentia out-licensed the exclusive rights to develop and commercialize ropeginterferon alfa-2b to AOP Orphan in PV, other MPNs, and CML for European, Commonwealth of Independent States (CIS), and Middle Eastern markets.
Related news and insights
Zai Lab Limited and its partner Entasis Therapeutics Holdings Inc. announced topline results from the ATTACK trial, a global Phase III registrational trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter baumannii.
Oyster Point Pharma, Inc. announced that the FDA has approved Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease.