The European Commission on Monday gave its approval for blood-thinning drug Efient for heart patients with acute coronary syndrome undergoing an artery-opening procedure. Acute coronary syndrome includes heart attacks and chest pain.

 

Efient, also known as prasugrel, is made by Eli Lilly and Co. in a joint with Japan’s Daiichi Sankyo Co. The European approval follows the recommendations of the Committee for Medicinal Products for Human Use of the European Medicines Agency, which backed the drug on December 18, 2008.

 

Efient reduces the ability of platelets to stick or clump together, which can cause clogged arteries and lead to a heart attack. The drug will compete with blood thinner Plavix made by Bristol Myers Squibb Co and Sanofi-Aventis. Plavix is the world’s second best-selling drug with more than $7 billion in 2007 global sales.

 

In a study of both Lilly and Daiichi, Efient was associated with three fewer heart-related deaths than blood thinner Plavix.

 

“The approval of prasugrel helps to meet an important medical need. Survivors of heart attacks have a substantial risk of suffering from one or more additional heart attacks. This action is a major step forward in giving healthcare professionals and patients in European countries a new antiplatelet option for treating ACS,” said John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Lilly.

 

Earlier this month a panel of nine members of the Cardiovascular and Renal Drugs Advisory Committee recommended the drug for approval in the United States. Prasugrel was submitted for approval in January 2008 and since then the FDA had twice put off making a decision because the drug’s side effects, including internal bleeding.

 

Lilly spokeswoman Carole Copeland said the company “is working diligently” with the Food and Drug Administration, “as they continue their review” on Efient.