Swedish Orphan Biovitrum AB (publ) http://www.sobi.com/ (Sobi(TM)) and collaboration partner Biogen have received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA) recommending the European Commission (EC) to maintain the orphan designation for Alprolix® (eftrenonacog alfa), a recombinant factor IX Fc fusion protein therapy for the treatment of haemophilia B. The COMP’s recommendation is now referred to the EC which is responsible for granting marketing authorisation for medicines in the EU.
An application for marketing authorisation was submitted to EMA in June 2015. In February 2016, Sobi and Biogen received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of EMA for Alprolix. If approved and the orphan designation is confirmed, Alprolix will remain on the Community Register of Orphan Medicinal Products and receive orphan designation.