Daiichi Sankyo Company, Limited, and Eli Lilly and Company announced 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, 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, 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.
Daiichi Sankyo Eli Lilly 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.