Eli Lilly, Daiichi Sankyo submit application for Effient to FDA

WASHINGTON Eli Lilly and Daiichi Sankyo have submitted an application for their drug prasugrel, which will be sold under the name Effient, to the Food and Drug Administration for approval.

Prasugrel is a blood-thinning drug that was initially developed to treat patients with acute coronary syndrome who are managed with percutaneous coronary intervention, including coronary stenting.

The application is based on data from several trials, including the TRITON-TIMI 38 clinical trial, which evaluated the safety and efficacy of prasugrel compared with clopidogrel (sold under the trade names Plavix and Iscover), Eli Lilly said.