Novo Nordisk nabs FDA approval for hemophilia fighter NovoEight

Novo Nordisk is known for its dominance in the diabetes market. The company sports 5 of the 10 top-selling diabetes remedies worldwide. But the company has a stash of other treatments, and it just added one to the mix. The FDA gave its blessing to Novo's new factor VIII treatment for hemophilia A, NovoEight (turoctocog alfa).

It's the first of several hoped-for approvals in the bleeding-disorders field. Novo ($NVO) wants to work its way into pole position in the hemophilia market, with several treatments in its late-stage pipeline. And it already has a beachhead there; its NovoSeven treatment for hemophilia A and B brought in $1.5 billion last year, despite the loss of some IP protections in the U.S. and elsewhere.

Novo isn't as hopeful about NovoSeven's prospects; the company has said it's expecting sales to decline. So, NovoEight's approval is a step toward replacing those revenues. The company doesn't plan to launch NovoEight in the U.S. 'til early 2015, however, for fear of stepping on some unspecified "third-party" patents, PMLive reports. Europe's Committee for Medicinal Products for Human Use (CHMP) gave a thumbs-up to NovoEight last month, and Novo expects to launch in Europe early next year.

Snapping up market share in bleeding disorders won't be easy. Novo has some established rivals, including Baxter ($BAX), Bayer and Pfizer ($PFE), and Biogen Idec ($BIIB) is developing its own challenger. Plus, it has already met with a couple of setbacks. In June, Novo announced that the FDA refused to approve rFXIII, its new treatment for the rare bleeding disorder congenital factor XIII deficiency. The agency cited problems with Novo's manufacturing, which the company says it's addressing now. And last year, the drugmaker canned another potential entry in hemophilia, vatreptacog alfa, after some patients developed antibodies to the treatment. On the sunnier side, a Phase III trial of its N9-GP drug for hemophilia B turned in positive results earlier this year.

- read the Novo announcement
- get more from PMLive
here's FierceBiotech's take

Special Reports: Top 20 Orphan Drugs by 2018 - NovoSeven | 10 Top-Selling Diabetes Drugs