The FDA has granted priority review to Eli Lilly and Daiichi Sankyo's prasugrel, an anti-clotting drug. The NDA for prasugrel was submitted to the agency in December. Now the drugmakers can expect an FDA ruling in just six months, rather than the 10 months is usually takes for a drug to receive approval. Lilly has a lot riding on prasugrel's approval, as many industry watchers say the company has no other blockbuster hopefuls in its pipeline. Both companies' shares rose on the news.
"We are greatly pleased to learn that the FDA has determined the application meets its criteria for such a review, and we look forward to working with the agency as it continues its review process," said Dr. J. Anthony Ware, Lilly vice president for cardiovascular/acute care.
- see this release
- check out the Wall Street Journal article for more