FDA Clears Rebinyn for Hemophilia B

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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.

Mega Doctor News

Bagsværd, Denmark, 31 May 2017 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® for the treatment of adults and children with haemophilia B.

REBINYN® is the brand name for nonacog beta pegol; N9-GP. REBINYN® is indicated for on-demand treatment and control of bleeding episodes and the perioperative management of bleeding around the time of surgery in adults and children with haemophilia B. The efficacy and safety evaluation was based on 115 patients across the four paradigm clinical trials, and the approval follows the Blood Products Advisory Committee meeting held 4 April 2017.

“We are excited about the approval of REBINYN® in the US, and we consider it an important expansion of the treatment options for patients with haemophilia B”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “We are confident that REBINYN® will become an important tool for physicians to help patients manage their bleeds.”

Novo Nordisk expects to launch REBINYN® in the US in the first half of 2018.

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