PHARMA/BIO-TECH UPDATE – Biogen says FDA extends review of Long-Acting Hemo B drug

Biogen Idec announced this morning that the US Food & Drug Administration (FDA) will extend the initial Prescription Drug User Fee Act date of its review of the company’s experimental long-acting, recombinant Hemophilia B drug, Alprolix.

Hemophilia B is a rare bleeding disorder that effects the ability of the patient’s blood to clot when necessary.

Described by Biogen as the first major treatment advance for Hemophilia B patients in 15 years, has provided the FDA with additional information related to validation and manufacturing of its factor IX medicine.  The company claims that Alprolix helped control bleeding during and after 14 major surgeries in 12 patients with Hemophilia B.

[In November, webleed reported on the FDA delay of Biogen’s Hemophilia A drug.]

Alprolix is also under review by regulatory authorities in several other countries, including Canada, Australia, and Japan.

Photo Credit: Reuters/Brian Snyder