June 24, 2008
FDA Extends Review Period for Daiichi Sankyo and Eli Lilly’s Antiplatelet Drug
Daiichi Sankyo Company and Eli Lilly and Company have said that the FDA has extended the review period for the prasugrel new drug application based on supplemental information provided during the review period.
This three-month extension allows the FDA time to complete its review. The prasugrel new drug application was granted priority review by the FDA in February 2008. The new FDA action date for prasugrel is September 26, 2008.
The proposed indication for prasugrel is for the treatment of patients with acute coronary syndromes (ACS) being managed with an artery-opening procedure known as percutaneous coronary intervention.
Daiichi Sankyo and Lilly also confirm the start in June 2008, as planned, of the Trilogy ACS trial, a large Phase III clinical trial to compare the effects of prasugrel against clopidogrel (Plavix/Iscover) in medically managed ACS patients.
John Alexander, global head of R&D at Daiichi Sankyo, said: "The initiation of the Trilogy ACS trial demonstrates our continued commitment to investigate prasugrel as a potential therapy for ACS patients who are medically managed."