FDA Approves Biogen Idec's Eloctate For Hemophilia A
The U.S. Food and Drug Administration (FDA) announced its approval of Biogen Idec’s Eloctate, the first antihemophilic factor (recombinant), Fc fusion protein for hemophilia A.
Eloctate consists of the Coagulation Factor VIII molecule linked to the protein fragment Fc found in antibodies. This makes Eloctate the first recombinant clotting factor VIII therapy to show prolonged circulation in the body. The drug is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adult and pediatric patients with hemophilia A.
Hemophilia A is a blood clotting disorder that primarily affects males. The disease is caused by Factor VIII gene defects, which causes repeated episodes of serious bleeding. Hemophilia A afflicts one in every 5,000 males in the U.S.
“Prophylactic treatment is recommended for people with severe hemophilia, and following a protective regimen can be burdensome given the frequency of infusions required. Infusion frequency is a major challenge for people with hemophilia, and I believe Eloctate begins to address this burden while protecting against bleeding episodes,” Patrick F. Fogarty, director of Penn Comprehensive Hemophilia and Thrombosis Program.
Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said, “The approval of this product provides an additional therapeutic option for use in the care of patients with Hemophilia A.”
The FDA approved Eloctate under an Orphan Drug designation. The approval was supported by positive data from a clinical trial involving 164 patients, where Eloctate demonstrated efficacy in the treatment of bleeding episodes, preventing or reducing bleeding and control of bleeding during and after surgical procedures.
George A. Scangos, CEO of Biogen Idec, said, “As a company deeply committed to improving the lives of people with hemophilia, we are excited to bring this important innovation to those living with hemophilia A.”
Biogen Idec said it intends to market Eloctate in the U.S. in July of this year following the regulatory approval.