Biogen Idec announced today that the FDA has accepted the company's new hemophilia B drug application and will begin its regulatory review. The review is expected to take 10 months, according to the AP.
Hemophilia B is a rare, inherited disorder in which the ability of a person's blood to clot is impaired.
Biogen's recombinant factor IX Fc fusion protein (rFIXFc) is a clotting factor that uses the company's FDA-approved proprietary monomeric Fc fusion technology to provide longer-lasting protection from bleeding.
"We are encouraged by the FDA's acceptance of our application, as we believe rFIXFc has the potential to transform the care of hemophilia B by allowing for less frequent injections and helping patients to maintain low annualized bleeding rates," Dr. Glenn Pierce, a senior vice president of Biogen Idec, is quoted as saying in the company press release. "We are working with the FDA to bring the first major treatment advance for the hemophilia B community in 15 years."
Not only does the drug potentially provide better protection from bleeding, but it can also significantly reduce the 100+ injections a year some hemophilia B patients now receive to aid clotting, according to Biogen Idec. The compay says B-LONG, the largest registrational phase 3 clinical study ever conducted for hemophilia B, supported these findings.
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