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February 16, 2021Libtayo Receives New Lung Cancer Indication
February 22, 2021FDA Partially Rescinds Approvals for Two Hemophilia B Treatments
February 17, 2021 – The U.S. FDA has partially rescinded approvals for Pfizer’s BeneFIX® (coagulation factor IX, recombinant) and Medexus Pharma’s Ixinity® (coagulation factor IX, recombinant).
In 2020, the FDA approved both drugs for routine prophylaxis to reduce the frequency of bleeding episodes in patients diagnosed with hemophilia B. However, Shire’s Rixubis® (coagulation factor IX, recombinant) had previously been granted seven-year orphan drug exclusivity for the same indication.
BeneFIX and Ixinity can continue to be used for routine prophylaxis in adults who have hemophilia B, as the period of exclusivity for this patient population expired in June 2020. The period of exclusivity for pediatric patients is expected to end in September 2021.
All three drugs are also indicated to provide on-demand treatment and control of bleeding episodes as well as perioperative management of bleeding for patients who have hemophilia B.