ZymoGenetics says that the FDA will not need another clinical trial for rhThrombin, an experimental spray to reduce bleeding during surgery. Company officials say the decision by the FDA could reduce the time it takes to get the therapy to market by 18 months and significantly reduce its development costs. The agency accepted the therapy for review in February and is scheduled to give a decision by mid-October. The therapy is a recombinant form of human thrombin. Currently, the only stand-alone thrombin available in the U.S. is derived from bovine blood. Novo Nordisk has a 32 percent stake in ZymoGenetics.
- here's the release
- read the AP report on the FDA's decision