Biogen Snags FDA Approval for Second Hemophilia Drug
The U.S. FDA said on Friday it approved Biogen Idec's long-lasting hemophilia A drug, Eloctate, adding another product to the company's emergent portfolio of non-malignant blood disorder drugs.
According to Biogen, Eloctate is the first recombinant hemophilia A therapy with prolonged circulation in the body. It is the only treatment for hemophilia A to reduce the frequency of bleeding episodes with prophylactic infusions every three to five days, offering people with hemophilia A the potential to extend the interval between prophylactic infusions
The FDA's ruling followed the March approval of Biogen's milestone hemophilia B treatment, Alprolix, the first recombinant, DNA derived hemophilia B therapy with prolonged circulation in the body.
Biogen developed both Alprolix and Eloctate with Swedish specialty health care company Sobi and plans to make Eloctate commercially available to people with hemophilia A in the United States in July 2014.
Read the Biogen company press release