Eli Lilly and Daiichi Sankyo are celebrating the news that regulators in Europe have recommended approval for their highly-anticipated bloodthinner prasugrel.

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 undergoing percutaneous coronary intervention. The recommendation is now passed onto the European Commission, which will decide whether to approve the drug, which will be sold as Efient, in two to three months.

The CHMP’s recommendation is largely based on the TRITON-TIMI 38 trial, a head-to-head superiority study that evaluated prasugrel compared with Sanofi-Aventis/Bristol-Myers Squibb’s Plavix (clopidogrel) in reducing atherothrombotic events in over 13,600 patients.

The TRITON trial threw up mixed results, in that prasugrel produced a 19% reduction in relative risk for the endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke when compared with Plavix. However, the data also revealed that prasugrel-treated patients experienced a statistically significant 32% increase in minor and major bleeding.

Lilly and Daiichi Sankyo are still confident that prasugrel will be approved in the USA though the Food and Drug Administration has twice delayed making a decision on the compound. A New Drug Application was submitted to the agency in December 2007, and in February the agency announced a six-month priority review for the application.

However, in June, the FDA announced it was delaying the application, saying that the weight of supplemental information filed on the drug meant it had to put back its action date by three months to September 26. The second deadline was also missed.