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Pharma/Biotech Update: FDA To Review New Hemophilia B Medication

February 4, 2015; Posted by: WeBleed staff

CSL Behring granted review by U.S. FDA for hemophilia B drug.

The United States Food and Drug Administration (FDA) has accepted for review CSL Behring’s Biologics License Application (BLA) for its long-acting fusion protein linking recombinant coagulation factor IX (9) with recombinant albumin. If approved, this would allow hemophilia B patients with another treatment option of dosing intervals of up to 14 days.

“FDA’s decision to accept for review the rIX-FP BLA brings CSL Behring one step closer to providing this innovative therapy to hemophilia B patients in the U.S.,” Dr. Andrew Cuthbertson, Chief Scientific Officer and R&D Director of CSL Limited said in a press release.  “The development of rIX-FP underscores CSL Behring’s protein science capabilities, thorough understanding of the hemophilia community, and commitment to improving the well-being of patients with hemophilia B.”

WeBleed will post updates as the outcome is announced.

Photo Credit – CSL Behring

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