16 May 2016 - Novo Nordisk today announced the submission to the US FDA of the Biologics License Application for the approval of long-acting factor IX, nonacog beta pegol.

Nonacog beta pegol is a glycopegylated recombinant factor IX with a significantly improved pharmacokinetic profile, developed for patients with haemophilia B.

The filing of nonacog beta pegol is based on the results from the paradigm clinical trial programme which involved 115 patients with severe or moderately severe haemophilia B. Nonacog beta pegol was found to be efficacious in routine prophylaxis, treatment of bleeding episodes and surgery for adults, adolescents and children. Furthermore, nonacog beta pegol appeared to be well-tolerated and no safety concerns were identified.

For more details, go to: http://www.novonordisk.com/media/news-details.2012939.html