Novo Nordisk wins FDA nod for hemophilia drug as pressure mounts

Novo Nordisk ($NVO) has secured FDA approval for Novoeight, a hemophilia biologic the drugmaker hopes will help make up for the slumping sales of an aging giant and dull the blow of impending competition.

Novoeight, formerly turoctocog alfa, is a recombinant factor VIII therapy that treats hemophilia A by replacing a key coagulation protein. In its Phase III trial on 210 patients with severe hemophilia A, Novoeight effectively prevented and treated bleeds without spurring inhibitor development, avoiding an issue that forced Novo to pull the plug on the once-promising vatreptacog alfa last year.

Hemophilia A affects about 350,000 people around the world, Novo said, and the FDA's blessing comes about a month after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended Novoeight for EU approval. Novo is eyeing April 2015 for the drug's launch.

The Danish drugmaker remains the world's largest insulin producer, but Novo is struggling to maintain its footing in hemophilia as sales wane for the once-mighty factor VIIa treatment Novoseven. Since last year's Phase III flop for vatreptacog alfa, Novo has endured a second FDA rejection for its recombinant factor XIII therapy, putting the squeeze on its hemophilia pipeline.

Meanwhile, competition is on the way. Biogen Idec ($BIIB) has raced to the FDA with Eloctate, a hemophilia A-treating recombinant factor VIII Fc fusion protein. The Boston biotech filed for approval in May after posting impressive late-stage data for its long-acting drug, and Biogen's factor IX candidate Alprolix, aimed at hemophilia B, is also undergoing agency review.

- read Novo's announcement
- here's FiercePharma's take

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