FDA the FDA has approved the use of Alprolix to help control and prevent bleeding episodes in adults and children suffering from Hemophilia B, as well as manage bleeding during surgical procedures, and reduce or prevent the frequency of bleeding episodes (prophylaxis).
Hemophilia B is an inherited sex-linked, blood-clotting disorder, which primarily affects males, and is the result of mutations in the Factor IX gene. Sometimes referred to as “Christmas Disease (after Stephen Christmas, the first patient diagnosed with the illness), it is the 2nd most common form of hemophilia, affecting approximately 3,300 people in the United States. It is also more prevalent in males. Patients with Hemophilia B often experience repeated episodes of potentially serious bleeding that can destroy their joints.
“Alprolix is the first Hemophilia B treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding.The approval of this product provides another therapeutic option for the treatment and prevention of bleeding in patients with Hemophilia B,” said Karen Midthun, M.D., director of the FDA’s Center for Biologics Evaluation and Research.