Biogen Inc (BIIB)

[Theo]

Biogen & Swedish Orphan Biovitrum receive 'positive' opinion from the Committee for Medicinal Products for Human Use of the EMA; recommends Alprolix for marketing authorization (BIIB)

2/27/2016 7:15 am:

Alprolix is a recombinant factor IX Fc fusion protein therapy for the treatment of hemophilia B. If approved, Alprolix would be among the first therapies in the EU to offer people living with hemophilia B prolonged protection against bleeding episodes with prophylactic dosing intervals, according to the co.

The positive opinion was based on results from two global, Phase 3 clinical trials that demonstrated the efficacy, safety, & pharmacokinetics of Alprolix for hemophilia B. The CHMP's recommendation is now referred to the European Commission
Sobi has final development & commercialization rights in the Sobi territory (essentially Europe, North Africa, Russia, & most Middle-Eastern markets); Biogen leads development & manufacturing for Alprolix, has commercialization rights in North America & all other regions in the world, excluding the Sobi territory