Novo gets a year-end win for Factor XIII blood-clotting product after two rejections

Three's a charm for Novo Nordisk ($NVO) and its recombinant Factor XIII compound for a rare bleeding disorder. After receiving a complete response letter (CRL) in 2012 and then again this August, the drugmaker has gotten FDA approval for Tretten. It is an end-of-the year win in what has been a sometimes difficult year for the Denmark-based company.

The FDA in an announcement Monday said Tretten is the first recombinant product for the rare clotting disorder known as congenital Factor XIII A-subunit deficiency. The patient population is small for the product, which received orphan drug status. It was tested on 77 patients with the condition.

The August CRL centered on issues at a plant found during an inspection. But Novo did not give up on it, like it did with another of its hemophilia products. Last year the company abandoned development of a Factor VIIa therapy after researchers found antidrug antibodies in patients. Novo has struggled some to advance its pipeline of treatments for hemophilia, working to build up its lineup of bleeding-disorder products behind its approved NovoSeven. While it has been dealing with setbacks, Biogen Idec ($BIIB) has moved along with two long-acting clotting factors for hemophilia A and hemophilia B treatments.

Of course, the earlier CRL for Tretten was nothing compared to Novo Nordisk's setback for Tresiba, the long-acting insulin drug that it had expected to power its earnings into the near future. In February, the FDA refused to approve Tresiba and its sister drug Ryzodeg without more safety data. The drugmaker has said it will take two to three years to get the agency what it wants. Adding to its Tresiba frustrations, security regulators in Denmark two weeks ago called in law enforcement to explore why Novo took two days before announcing to shareholders the FDA setback for the insulin product.

While the Tresiba upset was a hard hit for the drugmaker, CEO  Lars Rebien Sørensen has taken every opportunity to remind investors it was not the company's only product. He has pointed out that Novo remains the leader in diabetic care with 27% of the market and has a pipeline of insulin products that he says should keep it in growth mode. While the drugmaker continues to grow, that expansion has slowed as growth in sales of Victoza, its Type 2 diabetes powerhouse, have tapered off.  

- here's the FDA release
- here's Novo's announcement

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