CHMP recommends Alprolix (rFIXFc) for treatment of haemophilia B- SOBI + Biogen
Swedish Orphan Biovitrum AB and Biogen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorisation be granted for Alprolix (rFIXFc), a recombinant factor IX Fc fusion protein therapy for the treatment of haemophilia B. If approved, Alprolix would be among the first therapies in the European Union (EU) to offer people living with haemophilia B prolonged protection against bleeding episodes with prophylactic dosing intervals.
The positive opinion was based on results from two global, Phase III clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix for haemophilia B: the pivotal B-LONG study for previously treated adults and adolescents, and the Kids B-LONG study for previously treated children under age 12. The CHMP's recommendation is now referred to the European Commission (EC), which is responsible for granting marketing authorisation for medicines in the EU.
Comment: Baxalta's twice-weekly Rixubis will compete with Alprolix for hemophilia B. Rixubis is also CHMP recommended and was FDA approved in 2013.
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