FDA Extends Review Period for Prasugrel
DAIICHI SANKYO confirm the start of TRILOGY ACS clinical trial to study Prasugrel against Clopidogrel in medically managed ACS patients
TOKYO AND INDIANAPOLIS, Ind. (June 23, 2008) – DAIICHI SANKYO Company, Limited, (TSE:4568) and Eli Lilly and Company (NYSE: LLY) said that the U.S. Food and Drug Administration (FDA) has extended the review period for the prasugrel new drug application (NDA) based on supplemental information provided during the review period. This three month extension allows the FDA time to complete its review. The prasugrel NDA 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 (PCI).
DAIICHI SANKYO and Lilly also confirm the start this month, 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.
"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."
"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," said John Alexander, M.D., M.P.H., global head of research and development, DAIICHI SANKYO Company, Limited.
About Trilogy ACS
The study, TRILOGY ACS (TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes), will include approximately 10,000 patients at more than 800 hospitals in 35 countries. DAIICHI SANKYO and Lilly are conducting the study in conjunction with the Duke Clinical Research Institute (DCRI), the world’s largest academic clinical research organization
and a part of Duke University Medical Center.
The study is a multi-center, double-blind, randomized, controlled trial to evaluate the safety and efficacy of prasugrel against clopidogrel in reducing the risk of cardiovascular death, heart attack or stroke in ACS patients who are to be medically managed without a
planned artery-opening procedure.
Acute coronary syndromes, which comprises heart attacks and unstable angina (chest pain), affects more than 1.4 million people in the United States annually.1 Despite currently available treatments, 320,000 people experience recurrent heart attacks each year.2
Contact:
Kim Wix
DAIICHI SANKYO (U.S.A.)
973-695-8338 (office)
908-656-5447 (cell)
Shigemichi Kondo
DAIICHI SANKYO (Tokyo)
81-3-6225-1126 (office)
1 American Heart Association. Heart Disease and Stroke Statistics – 2008 Update. Dallas, TX. American Heart Association. (Pg. 14)
2 American Heart Association. Heart Disease and Stroke Statistics – 2008 Update. Dallas, TX. American Heart Association. (Pg. 12)
Forward-looking statements
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