FDA Approves Biogen Idec's ALPROLIXT
Biogen Idec has announced that FDA has approved ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein], the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body. ALPROLIX is indicated for the control and prevention of bleeding episodes, perioperative (surgical) management and routine prophylaxis in adults and children with hemophilia B. The therapy is shown to reduce bleeding episodes with prophylactic (protective) infusions starting at least a week apart.
The approval of ALPROLIX is the first significant advance in hemophilia B treatment in more than 17 years. The therapy is clinically proven to reduce bleeding episodes with a favorable safety and tolerability profile. It is developed using a process called Fc fusion and is the first hemophilia therapy to demonstrate prolonged circulation in the body, which has been shown in adults and adolescents with hemophilia to extend the time between prophylactic infusions.
“The FDA approval of ALPROLIX is a significant milestone for the hemophilia B community, and represents an important first step in our commitment to transform the care of people with hemophilia,” said George A. Scangos, PhD, chief executive officer of Biogen Idec. “ALPROLIX offers people with hemophilia B the ability to prevent or reduce bleeding episodes with prophylactic infusions starting at least a week apart. We believe this new therapy will help more people with hemophilia and their caregivers realize the benefits of this treatment approach.”
The National Hemophilia Foundation (NHF) recommends routine prophylaxis as optimal for the treatment of people with severe hemophilia. Studies show people with severe hemophilia who follow this type of regimen experience fewer bleeding episodes and their related risks. Complications of bleeding episodes may range from severe swelling and pain to arthritis, joint damage and physical disability.1,2,3
“Hemophilia has a significant impact on people whom it affects, throughout their lives,” said Patrick F. Fogarty, M.,4 assistant professor of medicine at the Hospital of the University of Pennsylvania, and director, Penn Comprehensive Hemophilia and Thrombosis Program. “ALPROLIX addresses a critical need by allowing people with hemophilia B to maintain factor levels with prophylactic infusions once weekly or once every 10 days. We hope this will facilitate use of prophylactic therapy.”
1. Nilsson IM, Berntorp E, Löfqvist T, Pettersson H. Twenty-five years' experience of prophylactic treatment in severe haemophilia A and B. J Intern Med 1992;232:25-32.
2. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med 2007;357:535-44.
3. Panicker J, Warrier I, Thomas R, Lusher JM. The overall effectiveness of prophylaxis in severe haemophilia. Haemophilia 2003;9:272-8.
4. Editor’s Note: Dr. Fogarty has received researched support, and fees for consulting, from Biogen Idec.
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