The U.S. Food and Drug Administration (FDA) expanded approval of coagulation factor IX (FIX; recombinant) GlycoPEGylated for hemophilia B. The treatment, which is used to replace clotting factor IX, is now approved for prophylactic use to reduce bleeding episodes.
In 2017, the FDA approved the treatment for controlling bleeding episodes on demand and managing perioperative bleeding. Approval expansion was based on the results of five multi-center studies that observed 15,167 injections.
The studies showed that both adults and adolescents with hemophilia B who received the prophylactic treatment “experienced [FIX] activity in the same range as people without hemophilia (above 40%) for nearly 80% of the week,” said Allison P. Wheeler, MD, of Vanderbilt University Medical Center in Nashville. “This is supported by the World Federation of Hemophilia acknowledgment that replacement therapy with extended half-life FIX allows for more ambitious prophylaxis.”
Across all studies, the most common adverse events observed in patients were injection site reactions and itching.
Source: Novo Nordisk, July 29, 2022.
