USA – FDA partially rescinds two approvals after orphan exclusivity mix-up

The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last week partially rescinded the approval of two supplemental biologics license applications (sBLAs) for recombinant factor IX products after determining that part of the products’ indications were covered by orphan drug exclusivity.
Last year, FDA approved sBLAs for Wyeth Pharmaceuticals’ BeneFIX and Aptevo BioTherapeutics’ Ixinity, granting both products new indications for routine prophylaxis in adults and children with hemophilia B to reduce the frequency of bleeding episodes.
However, in letters to both companies dated 17 February, FDA explains that it erred in approving the pediatric portion of the prophylaxis indications because they were covered under the seven years of orphan drug exclusivity awarded to Baxalta’s recombinant factor IX product Rixubis…