Pharma/Biotech Update: CSL Behring Submits New Drug to FDA
December 16, 2014; Posted by: WeBleed staff
After successful studies, CSL Behring submits application for FDA approval.
According to a recent news article released by the website MPR, CSL Behring is officially submitting a Biologistics License Application (BLA) to the United States Food and Drug Administration (FDA) for the new factor IX, hemophilia B product called rIX-FP. So what does this mean? CSL experienced successful Phase 2 & 3 studies recently that compared on-demand treatment to a weekly prophylaxis regimen as well as the number of patients who developed inhibitors (antibodies) against factor IX. In 2012, the FDA granted Orphan Drug designation to rIX-FP for the treatment and prophylaxis of bleeding episodes in patients with hemophilia B.
WeBleed will continue to post updates as the status and decision from the FDA becomes available.
Photo Credit – CSL Behring
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