Biogen and Sobi recently reported new data related to the company’s extended half-life therapy ELOCTATE™, a recombinant factor VIII Fc fusion protein (rFVIIIFc) therapy designed to keep the infused clotting factor circulating in the body longer, stretching the time between infusions. Biogen and Sobi collaborate on the development and commercialization of ELOCTATE™ (Elocta® in Europe) and another extended half-life product ALPROLIX®, a recombinant factor IX (rFIX) Fc fusion protein therapy indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B.
ELOCTATE™ is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A (factor VIII deficiency). The data, which focused primarily on safety and efficacy, were presented at the 58th Annual Meeting of the American Society of Hematology (ASH), held December 3-6, 2016, in San Diego, CA.
The efficacy data presented at ASH reflected low target joint annual bleeding rates and effective target joint resolution (less than two spontaneous bleeding episodes over one year) in pediatric, adolescent and adult patients on long-term prophylaxis with ELOCTATE™. Target joints occur when a person with hemophilia experiences chronic bleeds in the same joint, often leading to joint disease. The company reported an 18% improvement in hemophilia-related quality of life measures (Haem-A-QOL) in adolescents and adults who experienced target joint resolution. The most significant impact was seen in areas such as physical health, sports, leisure activities, work and school.
Biogen also presented preclinical data on recombinant FIXFc-XTEN, a fusion protein being investigated for weekly subcutaneous (administered under the skin) therapy for people with hemophilia B. The rFIXFc-XTEN program is currently being developed solely by Biogen and uses XTEN® technology licensed from the biotechnology company Amunix.
“We are encouraged to see data that show ELOCTATE can improve the quality of life for people with hemophilia A,” said Krassimir Mitchev, MD, PhD, vice president and medical therapeutic area head of Haemophilia at Sobi. “Sobi, together with Biogen, is strongly committed to ensuring sustainable access to ELOCTATE/Elocta for people living with hemophilia A across our respective markets.”
Source: Business Wire, December 3, 2016
