Novo Nordisk’s Rebinyn Approved by FDA to Treat Hemophilia B

The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s Rebinyn (coagulation factor IX [recombinant], glycopegylated) to treat hemophilia B in adults and children. Rebinyn, brand name for nonacog beta pegol (N9-GP), is indicated for ondemand treatment and control of bleeding episodes and the perioperative management of bleeding. It is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B. Approval was based on the efficacy and safety evaluation of 115 patients across the four paradigm clinical trials.

“We would liketo thank the patients who participated in the clinical studies that led to this decision. Thanks to their commitment, we are able to continue to provide new medicines for people with hemophilia,” said Bill Breitenbach, vice president of biopharmaceuticals portfolio at Novo Nordisk. “We are committed to the hemophilia community and will continue on our path to bring this new extended half-life treatment to patients who need it.”