The committee reviewed comprehensive data primarily from the Triton TIMI-38 clinical trial. Results from the Triton trial showed that prasugrel taken with aspirin reduced the relative risk of the combined endpoint of cardiovascular death, non-fatal heart attacks or non-fatal stroke by 19% more than clopidogrel (Plavix/Iscover) taken with aspirin. These benefits were accompanied by an increased risk of serious bleeding with prasugrel overall, some of which included life-threatening and even fatal bleeding, the two companies said.
FDA reviewers will consider the panel’s favorable recommendation in the review of the new drug application that Lilly submitted for prasugrel on behalf of the alliance with Daiichi Sankyo in December 2007.
Anthony Ware, Lilly vice president and cardiovascular/acute care platform leader for prasugrel, said: “We will continue to work closely with the FDA as the agency moves toward an action on the new drug application for prasugrel. It is important for patients to have multiple treatment options, and currently, acute coronary syndrome patients undergoing percutaneous coronary intervention have few options.”