Pharmaprojects R&D Pipeline News Feed
EU Approval for prasugrel
04 Mar 2009
Eli Lilly and Daiichi Sankyo have announced the EU approval of their blood-thinning drug Efient (prasugrel), for the prevention of atherothrombotic events in patients with acute coronary syndrome (ACS) managed with percutaneous coronary intervention (PCI).
The approval follows receipt of a positive CHMP opinion from the EMEA and a successful Phase III study (TRITON TIMI-38) in 13,608 ACS-PCI patients. The results showed prasugrel to be superior to Plavix, the current standard of care produced by Bristol-Myers Squibb and Sanofi-Aventis, reducing the relative risk for the composite endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 19%.
Prasugrel provides an antiplatelet option for treating ACS, which affects over 700,000 people in the European Union alone each year. The US FDA is currently evaluating a registration filing for prasugrel, which has been approved for priority review and has received a recommendation for approval. It is also in Phase II clinical trials in both Canada and Japan.
