Biogen and SOBI's MAA for Alprolix validated by EMA
The marketing authorization application for Alprolix from US biotech firm Biogen (Nasdaq: BIIB) and Swedish Orphan Biovitrum (Sobi) has been validated by the European Medicines Agency.
Alprolix is a recombinant factor IX Fc fusion protein product candidate for the treatment of hemophilia B. The application includes results from two global Phase III trials examining the efficacy, safety and pharmacokinetics of Alprolix in this indication: the pivotal B-LONG study for previously-treated adults and adolescents and Kids B-LONG for previously-treated children under 12.
Alprolix is currently approved for the treatment of hemophilia B in the USA, Canada, Japan and Australia, and is the only approved hemophilia B therapy to demonstrate prolonged clotting factor circulation in the body.
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