Novo Nordisk files for EU approval of haemophilia B treatment
Friday, January 08, 2016
Novo Nordisk A/S says files for regulatory approval of long acting factor IX, nonacog beta pegol, in the EU for the treatment of haemophilia B.
Say expects to file biologics license application (BLA) for nonacog beta pegol to U.S. Food and Drug Administration (FDA) during first half of 2016.
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 is an extended half-life factor IX molecule intended for replacement therapy in patients with haemophilia B.
Glycopegylation, the prolongation technology used for the half-life extension, is a novel approach in haemophilia B, already proven safe and efficacious in haemophilia A and other therapeutic areas.
reuters.com
