FDA approves Alprolix for bleeding prevention in Haemophilia B - Biogen

The FDA has on 28 March 2014, approved Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein], from Biogen, the first recombinant, DNA derived Haemophilia B therapy with prolonged circulation in the body. Alprolix is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with Haemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.

The approval of Alprolix is the first significant advance in Haemophilia B treatment in more than 17 years. The therapy is clinically proven to reduce bleeding episodes with a favourable safety and tolerability profile. It is developed using a process called Fc fusion and is the first Haemophilia therapy to demonstrate prolonged circulation in the body, which has been shown in adults and adolescents with Haemophilia to extend the time between prophylactic infusions.

The approval of Alprolix is based on results from the global, Phase III B-LONG study, as well as interim pharmacokinetic (measurement of the presence of the therapy in a person�s body over time) and safety data from the Phase III Kids B-LONG study. B-LONG study results showed that adults and adolescents with severe Haemophilia B achieved prevention or reduction of bleeding episodes with prophylactic infusions at least a week apart.