The E.U. Commitee for Medicinal Products for Humans Use (CHMP) said that Eli Lilly & Co and Daiichi’s experimental antiplatelet, prasugrel (Effient), was suitable for use in preventing clots in patients who are to undergo percutaneous coronary intervention, or PCI, a procedure to widen narrowed arteries.

The product was also recommended by the Food and Drug Administration although it was twice delayed for approval (last time was September this year). During last November’s Reuter Health Summit, Daiichi's head of U.S. commercial operations said he was confident the drug -- which will be marketed as Effient -- would soon win U.S. approval.

Daiichi said last October that they expected the drug to be launched by April 2009. Rumours accounted some time ago, said that a new FDA advisory panel would meet next February to define the drugs immediate approval situation.

Effient targets to compete with Bristol-Myers Squibb and Sanofi-Aventis SA blockbuster Plavix (Clopidogrel) although there are many speculative opinions about the real sale potential of the experimental drug, mainly due to the risk of bleeding associated with the product.

In a pivotal clinical study that pitted prasugrel against Plavix, the Lilly and Daiichi drug was 19 percent more effective than Plavix in preventing cardiovascular death, nonfatal heart attacks and strokes. But it was 32 percent more likely to cause serious bleeding.

Pasugrel is an investigational oral antiplatelet agent, 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.

EMEA will decide within the next 60 days if they approve marketing of Effient in the E.U.

Acute coronary syndrome, affects nearly 1.5 million people in the United States annually, and is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.