Eloctate Approved for Hemophilia A
Drug seeks to mitigate challenge of infusion frequency while protecting against bleeding episodes.
Drug seeks to mitigate challenge of infusion frequency while protecting against bleeding episodes.
Late Friday afternoon, Biogen Idec announced the FDA has granted orphan drug approval of Eloctate [Antihemophilic Factor (Recombinant), Fc Fusion Protein] for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia A.
Hemophilia A is a rare, chronic, genetic disorder that results in impaired clotting mechanisms due to missing or reduced levels of factor VIII. People with hemophilia A experience recurrent and extended bleeding episodes that cause pain and irreversible joint damage. Some of these bleeding episodes can be life-threatening. There are an estimated 16,000 people in the United States with hemophilia A (and 142,000 world wide). Orphan approved drugs are available to treat bleeding episodes and two orphan drugs - Advate and Kogenate - are approved for prophylactic use in patients with hemophilia A.
The recommended starting prophylactic regimen for Eloctate is 50 IU/kg every 4 days. Based on clinical response, the dose may be adjusted in the range of 25 to 65 IU/kg, every 3 to 5 days.
In a press release, Patrick F. Fogarty, MD, assistant professor of medicine at the Hospital of the University of Pennsylvania, and director, Penn Comprehensive Hemophilia and Thrombosis Program, said, “Prophylactic treatment is recommended for people with severe hemophilia, and following a protective regimen can be burdensome given the frequency of infusions required,” adding “Infusion frequency is a major challenge for people with hemophilia, and I believe ELOCTATE begins to address this burden while protecting against bleeding episodes.”
