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.

About REBINYN®

REBINYN® (nonacog beta pegol; N9-GP) is an extended half-life factor IX molecule for replacement therapy in patients with haemophilia B. The review of REBINYN® was based on the paradigm programme, a phase 3 clinical programme enrolling children and adults with severe or moderately severe haemophilia B. In the programme, 115 previously treated patients had a total of more than 8,800 exposure days for up to 2.7 years of treatment with REBINYN®. On 24 March 2017, Novo Nordisk received the positive opinion from the Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA), for nonacog beta pegol; N9-GP, indicated for prophylaxis and on-demand treatment of bleeding as well as for surgical procedures in adolescent (>12 years of age) and adult patients with haemophilia B.
    

Further information

Media:    
Katrine Sperling +45 3079 6718 krsp@novonordisk.com
Ken Inchausti (US) +1 609 786 8316 kiau@novonordisk.com
     
Investors:    
Peter Hugreffe Ankersen +45 3075 9085 phak@novonordisk.com
Hanna Ögren +45 3079 8519 haoe@novonordisk.com
Anders Mikkelsen +45 3079 4461 armk@novonordisk.com
Kasper Veje (US) +1 609 235 8567 kpvj@novonordisk.com

Company announcement No 40 / 2017