The US Food and Drug Administration (FDA) has approved nonacog beta pegol (Rebinyn, Novo Nordisk) for children and adults with hemophilia B, the company has announced.
Hemophilia B affects an estimated 5000 people in the United States. Factor IX is a naturally occurring clotting factor that is deficient in people with hemophilia B.
The active substance in Rebinyn, nonacog beta pegol, is a recombinant coagulation factor IX. It replaces the missing factor IX, thereby helping the blood to clot and giving temporary control of bleeding.
Rebinyn, given by infusion, is indicated for "on-demand treatment and control of bleeding episodes, and the perioperative management of bleeding in adults and children with hemophilia B," the company said in a news release. It is not indicated for routine prophylaxis or for immune tolerance induction in patients with hemophilia B.
Rebinyn comes in three dose strengths (500, 1000, and 2000 IU per vial).
The efficacy and safety of Rebinyn was demonstrated in a series of clinical trials involving 115 patients with severe or moderately severe hemophilia B. Common side effects of Rebinyn include swelling, pain, rash redness at the infusion site, and itching.
Novo Nordisk expects to launch Rebinyn in the United States in the first half of 2018. See full prescribing information is available online (http://www.novo-pi.com/rebinyn.pdf).
FDA Clears Rebinyn for Hemophilia BMedscape
June 1, 2017.