Prophylaxis Indication Restored for BeneFIX®

In February 2021, the U.S. Food and Drug Administration (FDA) partially rescinded a supplemental Biologics License Application (BLA) that the agency had granted, in error, for the recombinant factor IX product BeneFIX® (Pfizer). The temporary rescission centered on a specific indication for routine prophylaxis to reduce the frequency of bleeding episodes in children (<16 years of age) with hemophilia B. It had been granted by mistake, as another product already held orphan drug exclusivity until September 12^th of this year.

As of September 13^th, this indication for BenFIX® has been fully restored by the FDA. The product’s full set of indications now includes adults and children with hemophilia B (congenital factor IX deficiency or Christmas disease) for: on-demand treatment and control of bleeding episodes; perioperative management of bleeding; routine prophylaxis to reduce the frequency of bleeding episodes.

Access this link to view the updated prescribing information.

To see a complete list of products, go to Medical and Scientific Advisory Council (MASAC) Document 263 – MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Disorders.

Source: National Hemophilia Foundation, Septemver 2021