Swedish Orphan Biovitrum AB (Sobi’s) partner Biogen has submitted a Marketing Authorisation Application (MAA) for Alprolix (rFIXFc) to the European Medicines Agency (EMA). Sobi has an opt-in right to assume final development and commercialization of Alprolix in Europe, Russia, certain countries in the Middle East, and North Africa, according to Sobi. The MAA filing with the EMA along with the receipt of the opt-in data package permits the formal opt-in right for Sobi to exercise its option in accordance with the collaboration agreement, the company notes. 

Alprolix is a prolonged circulating recombinant factor IX Fc fusion protein product candidate for people with hemophilia B. 

Source: Sobi