Eloctate regulatory update

Health Canada approved Eloctate from Biogen Idec to control and prevent bleeding episodes and for routine prophylaxis in adults and children ages >=12 years with hemophilia A. In June, FDA approved Eloctate to control and prevent bleeding episodes, for perioperative management and for routine prophylaxis in adults and children with hemophilia A (see BioCentury, June 9). The product is also approved in Australia. Eloctate is a long-acting recombinant fusion protein consisting of the Fc domain of human IgG1 attached to Factor VIII.

In 2007, Swedish Orphan exercised an option to co-develop and commercialize Eloctate with Biogen Idec (see BioCentury, Nov. 12, 2007). Swedish Orphan also has an opt-in right to gain full development and commercialization rights to the product in Europe, Russia, the Middle East and Northern Africa. The company said it plans to exercise its opt-in right when the MAA is submitted. ...