Novo Nordisk ($NVO) is ending the year with an approval from the FDA. The agency announced yesterday that it is giving the green light to a new therapy dubbed Tretten to treat an extremely rare blood clotting disorder known as congenital Factor XIII A-subunit deficiency.
"Without treatment, people with this rare condition are at risk for serious and life-threatening bleeding," said Karen Midthun, M.D., director of the FDA's Center for Biologics Evaluation and Research. In a study with 77 patients, Novo found that Tretten prevented bleeding in 90% of the subjects.
It's unlikely to ever be a big seller for the pharma company, though. A group of three analysts tracked by Thomson Reuters provided an average peak sales estimate of $84 million.
- here's the release from the FDA
- here's the Reuters story