Biogen Idec submits FDA application for long-lasting hemophilia A treatment
Biogen Idec Inc., a Weston biotechnology company known for its multiple sclerosis drugs, said Tuesday that it is seeking regulatory approval for a long-lasting treatment for hemophilia A, a rare inherited disorder that impairs blood clotting.
Current treatments on the market can require a patient to get three or four injections a week. The hope for Biogen Idec’s treatment is that a patient would need only one or two injections per week. If approved, the treatment would be the first major advance for hemophilia A patients in more than two decades, Biogen Idec said.
In a dtetailed press release, the company said it has submitted a Biologics License Application to the US Food and Drug Administration for the marketing approval of recombinant factor VIII Fc fusion protein (rFVIIIFc) for the treatment of hemophilia A.
“This regulatory submission marks another significant step toward our goal of transforming the care of hemophilia for patients, families, and caregivers,” Glenn Pierce, M.D., chief medical officer of Biogen Idec’s hemophilia therapeutic area, said in a statement. “In our phase 3 study, patients treated with rFVIIIFc were able to inject rFVIIIFc once-weekly to twice-weekly, which creates the potential for those currently on prophylactic treatment to reduce injections by 50 to 100 per year. Moreover, patients currently treating bleeding episodes could potentially dose prophylactically once per week and maintain significant protection from bleeding with about the same total number of injections each year they use to treat bleeding episodes today.”Chris Reidy can be reached at firstname.lastname@example.org.