Biogen submits MAA for Alprolix (rFIXFc) at EMA for treatment of haemophilia B- SOBI + Biogen

Swedish Orphan Biovitrum AB (Sobi) announced that 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 commercialisation of Alprolix in Europe, Russia, certain countries in the Middle East, and North Africa. The MAA filing with the EMA coupled with the receipt of the opt-in data package, triggers the formal opt-in right, for Sobi to exercise its option in accordance with the collaboration agreement. Alprolix is a prolonged circulating recombinant factor IX Fc fusion protein product candidate for people with haemophilia B.

Comment: Alprolix is the first product candidate in a new class of long-lasting clotting factor therapies that are being developed with the goals of reducing the burden of treatment for this condition and enhancing protection from bleeding. The regulatory submission was based on results from B-LONG, the largest registrational phase III clinical study in Haemophilia B to date. Alprolix was approved by the FDA in March 2014.

Comment: Patients will now have the option of getting dosed every one or two weeks, as opposed to two or three times per week with existing treatments such as Pfizer's Benefix.