Biogen Idec (NASDAQ: BIIB) and Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) today presented new findings for their long-lasting recombinant factor IX candidate ALPROLIX * for hemophilia B at the XXIV International Society on Thrombosis and Haemostasis (ISTH) Congress in Amsterdam, The Netherlands. Three oral presentations showcase new data that reinforce the potential safety, efficacy and pharmacokinetic profile of ALPROLIX. The data highlight the consistency of results with ALPROLIX across patient types and favorable physician ratings of its efficacy in treating acute bleeding episodes and controlling bleeding during and after major surgery.
“ALPROLIX is the first product candidate in a new class of long-lasting clotting factor therapies, and the data presented today support the potential of the therapy to reduce the frequency of prophylactic infusions for patients with hemophilia B,” said Glenn Pierce, M.D., Ph.D., senior vice president of Global Medical Affairs and chief medical officer of Biogen Idec’s hemophilia therapeutic area. “These new data help to build the clinical profile of ALPROLIX by increasing our understanding of its efficacy.”
Treatment of Bleeding
An evaluation of the treatment of acute bleeding episodes across the prophylaxis and episodic (on-demand) treatment arms of the phase 3 B-LONG study showed that more than 90% of bleeds were controlled with a single injection of ALPROLIX and more than 97% were controlled with two or fewer injections. These data were showcased in the e-poster presentation:
- Treatment of Bleeding Episodes in Subjects with Haemophilia B with the Long-Lasting Recombinant Factor IX Fc Fusion Protein (rFIXFc) in the Phase 3 B-LONG Study
- Long-Lasting Recombinant Factor IX Fc Fusion (rFIXFc) for Perioperative Management of Subjects with Haemophilia B in the Phase 3 B-LONG Study
- Clinical Implications of Population Pharmacokinetics of rFIXFc in Routine Prophylaxis, Control of Bleeding and Perioperative Management for Haemophilia B Patients