Sobi

US FDA approves Alprolix(TM) - Seite 2

About the B-LONG Study
B-LONG was a global, open-label, multi-centre phase 3 study that evaluated the efficacy, safety and pharmacokinetics, of Alprolix in 123 males aged 12 years and older with haemophilia B. The study involved 50 haemophilia treatment centres in 17 countries on six continents.

The overall median annualised bleeding rates (ABR), or projected rate of bleeding episodes per year, reported in the study were 3.0 for weekly the prophylaxis arm, 1.4 for the individualised- interval prophylaxis arm and 17.7 in the on-demand treatment arm. For 12 study participants undergoing 14 major surgical procedures, treating physicians rated the ability of Alprolix to control bleeding as "excellent" or "good" in 100 per cent of these surgeries.

Common adverse reactions (incidence of greater than or equal to 1 per cent) from the B-LONG study were headache and oral paresthesia (an abnormal sensation in the mouth).

About Alprolix
Alprolix(TM) [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is the first recombinant, clotting factor therapy with prolonged circulation in the body. It is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with haemophilia B. Alprolix is not indicated for immune tolerance induction therapy, which is a treatment for people with inhibitors, and should not be used in individuals with a known history of serious allergic reactions. Alprolix is developed by fusing factor IX to the Fc portion of Immunoglobulin G Subclass 1, or IgG₁ (protein commonly found in the body). It is believed that this enables Alprolix to use a naturally occurring pathway to prolong the time therapy remains in the body. While Fc fusion has been used for more than 15 years, Biogen Idec is the only company to apply it in haemophilia.

About the Biogen Idec and Sobi Collaboration 
Biogen Idec and Swedish Orphan Biovitrum (Sobi) are partners in the development and commercialisation of Alprolix for haemophilia B. Biogen Idec leads development, has manufacturing rights, and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory. Sobi has the right to opt in to assume final development and commercialisation in Europe, including Russia, the Middle East and Northern Africa.