The Food and Drug Administration has approved Rebinyn (nonacog beta pegol, N9-GP) for the treatment of hemophilia B, according to a statement from Novo Nordisk.

Caused by deficient blood clotting factor IX activity, hemophilia B affects about 5,000 people in the United States. The disease is chronic and inherited and causes prolonged and spontaneous bleeding, particularly into muscles, joints, or internal organs. Rebinyn is intended to control and treat bleeding episodes, as well as provide perioperative management of bleeding.

The FDA has approved Rebinyn for both adult and pediatric patients, based on results from clinical trials comprising 115 hemophilia B patients. The most common side effects are swelling, pain, rash, or redness at the location of infusion and itching.

Find the full statement about Rebinyn’s approval on the Novo Nordisk website .