US FDA approved Novo Nordisk hemophilia A drug

Danish insulin giant Novo Nordisk (NOV: N) revealed this morning that the US Food and Drug Administration has approved its Biologics License Application (BLA) for recombinant coagulation factor VIII, NovoEight (turoctocog alfa).

The product will join a market sector valued at around $5 billion a year. The major treatments for hemophilia A include recombinant factor VIII drugs such as NovoSeven (from Novo Nordisk), Kogenate, Advate, ReFacto, Xyntha and Feiba.NovoEight has been studied in the guardian clinical program; one of the largest and most comprehensive pre-registration clinical trial programmes in the field of hemophilia therapy with more than 210 severe hemophilia A patients. In the completed trials NovoEight demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development, and all patients in the surgery trial were treated effectively. NovoEight will be launched with the newly introduced prefilled device, MixPro, the company noted.

Offers a new alternative

“The approval of NovoEight marks an important step in offering a new alternative for people with hemophilia A, and demonstrates our commitment to hemophilia,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk.