FDA Partially Rescinds Two Supplemental Biologics License Applications

The Center for Biologics Evaluation and Research (CBER), part of the U.S. Food and Drug Administration (FDA), partially rescinded two approvals of supplemental biologics license applications (sBLAs) for recombinant factor IX products. The sBLAs were approved by the FDA last year for Wyeth Pharmaceuticals’ BeneFIX and Aptevo BioTherapeutics’ Ixinity which granted new indications for routine prophylaxis in children and adults with hemophilia B for both products to reduce the frequency of bleeding episodes. The partial rescinding came after the CBER determined part of the product’s indications were covered by orphan drug exclusivity.

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