Novo Nordisk Files for Hemophilia B Treatment in the EUBy
Novo Nordisk has submitted to the European Medicines Agency the marketing authorization application for the approval of long-acting factor IX, nonacog beta pegol. Nonacog beta pegol is a glycopegylated recombinant factor IX with a improved pharmacokinetic (PK) profile, developed for patients with hemophilia B.
Nonacog beta pegol is an extended half-life factor IX molecule intended for replacement therapy in patients with hemophilia B. Glycopegylation, the prolongation technology used for the half-life extension, is a new approach in hemophilia B, and has already been proven safe and efficacious in hemophilia A and other therapeutic areas, according to Novo Nordisk.
Novo Nordisk expects to file the biologics license application (BLA) for nonacog beta pegol to the US Food and Drug Administration during first half of 2016.
Source: Novo Nordisk