DAIICHI SANKYO's Prasugrel receives positive opinion from the EU-Committee /// The positive opinion is now referred for final action to the EU-Commission.
TOKYO and INDIANAPOLIS, December 18, 2008 – DAIICHI SANKYO Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of prasugrel for the prevention of atherothrombotic events in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention (PCI).
The CHMP positive opinion is now referred for final action to the European Commission, which grants approval in the European Union. The Commission usually makes a decision about whether to approve a new drug candidate within two to three months of CHMP issuing its recommendation. Upon approval, this new oral antiplatelet agent is expected to be marketed throughout the European Union under the proposed brand name EFIENT™.
“We are extremely pleased by the CHMP positive recommendation for approval of prasugrel in Europe,” said John Alexander, M.D., M.P.H., global head of research and development, DAIICHI SANKYO Company, Limited. “Based on the study results and the positive recommendation, we are hopeful that prasugrel will be approved as a new treatment option for patients with ACS undergoing PCI.”
The submission package contains data from several trials, including the landmark TRITON-TIMI 38, a head-to-head superiority study that evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix®/Iscover®) in reducing atherothrombotic events (combined endpoint of cardiovascular death, non-fatal heart attack, or non-fatal stroke) in 13,608 patients with acute coronary syndromes undergoing PCI. These data were presented at the American Heart Association Scientific Sessions and simultaneously published online in the New England Journal of Medicine in November 2007.
“Cardiovascular disease remains a significant cause of death and disability worldwide, and this positive opinion is an important step in making this new treatment available to help prevent heart attacks in the ACS patient,” said J. Anthony Ware, M.D., Lilly vice president for cardiovascular/acute care.
Cardiovascular disease kills an estimated 17.5 million people worldwide each year, and acute heart attacks and unstable angina, called acute coronary syndromes, affect more than 800,000 people in Europe each year.1,2
About prasugrel
DAIICHI SANKYO Company, Limited (TSE: 4568), and Eli Lilly and Company (NYSE: LLY) are co-developing prasugrel, an investigational oral antiplatelet agent discovered by DAIICHI SANKYO and its Japanese research partner Ube Industries, Ltd., as a potential treatment, initially for patients with acute coronary syndromes who are undergoing PCI.
Prasugrel works by inhibiting platelet activation and subsequent aggregation by blocking the P2Y12 adenosine diphosphate (ADP) receptor on the platelet surface. Antiplatelet agents prevent platelets from clumping or sticking together, which can result in clogged arteries and may lead to heart attack or stroke. Lilly, on behalf of its alliance partner, DAIICHI SANKYO, submitted a Marketing Authorization Application for prasugrel to the European Medicines Agency in February 2008.
About Acute Coronary Syndromes
Acute coronary syndromes, which is comprised of heart attacks and unstable angina (chest pain), affects nearly 1.5 million people in the United States annually.3 ACS, a fatal consequence of coronary heart disease, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.4 Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits and cannot supply enough blood to the heart. In some cases, a blood clot may partially or totally block the blood supply to the heart resulting in ACS.5 Many ACS patients undergo PCI, which usually includes a stent placement.
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)
Carole Copeland (OUS)
Eli Lilly and Company
317-277-3661 (office)
317-610-6196 (cell)
Tammy Hull (U.S.A.)
Eli Lilly and Company
317-651-9116 (office)
317-614-5132 (cell)
1 World Health Organization
2 Bertrand M, CURE study investigator and Professor of Cardiology, University of Lille, France. Sanofi-Synthelabo and Bristol-Myers Squibb Company press release, “CPMP Recommends Granting Marketing Authorization In the European Union For Plavix®/Iscover® (clopidogrel) for the Treatment of Acute Coronary Syndrome with Non ST Segment Elevation,” June 27, 2002.
3 American Heart Association. Heart Disease and Stroke Statistics – 2008 Update. Accessed December 9, 2008.
4 British Heart Foundation Health Promotion Research Group. European Cardiovascular Disease Statistics 2008, Accessed December 9, 2008.
5 WebMD Medical Reference in Collaboration with the Cleveland Clinic. Heart Disease: Coronary Artery Disease. Accessed December 9, 2008.
