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Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that the European Commission (EC) has approved the transfer of the marketing authorisation for Alprolix® (eftrenonacog alfa), a recombinant clotting factor therapy developed for the treatment of haemophilia B, from Biogen[i] to Sobi, making Sobi the marketing authorisation holder (MAH) in the EU.
The EC has also approved the transfer of the orphan designation to Sobi. As MAH, Sobi will assume full regulatory responsibility for Alprolix in the EU.
The EC approval of Alprolix on 12 May 2016 was based on results from two global phase 3 clinical trials that demonstrated the efficacy, safety and pharmacokinetics of Alprolix for the treatment of 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.
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