Novo Nordisk files for EU approval of long-acting hemophilia B drug

7 January 2016

Danish diabetes care giant Novo Nordisk (NOV:N) today said it has made a submission to the European Medicines Agency of the marketing approval of its long-acting factor IX, nonacog beta pegol.

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

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.

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