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.
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