The FDA has extended by three months its review of the NDA for Effient, which was previously known by its generic name of prasugrel. The drug’s application was accepted in February 2008 and its deadline for action was this week. The new action date is September 26, 2008.

The proposed indication for Effient is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery-opening procedure known as percutaneous coronary intervention (PCI).

The three-month extension is intended to give FDA more time to complete its review of the drug, which demonstrated greater efficacy that market-leader Plavix, but also a possibility of greater side effects. The agency did not request additional trials from co-developers Daiichi Sankyo and Lilly as part of the NDA, but the companies do plan to begin a large Phase III trial to compare Effient and Plavix in medically managed ACS patients.

“We remain confident in our prasugrel submission package,” said Jennifer Stotka, M.D., vice president for Global Regulatory Affairs at Lilly. “The TRITON trial encompassed a large amount of data from over 13,000 patients. We will continue to work closely with the FDA throughout the review process and continue discussions to determine if any requirements under the new FDA Amendment Act (FDAAA) legislation will apply.”