An advisory panel of the US Food and Drug Administration on Tuesday voted unanimously to recommend approval of blood thinner prasugrel, made by Eli Lilly and Co. in a joint with Daiichi Sankyo Co., Ltd., for the treatment of acute coronary syndromes.

 

The panel, formed by nine members of the Cardiovascular and Renal Drugs Advisory Committee, based its decision on the pivotal Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel.

 

According to the findings, Prasugrel appears to reduce the risk of heart attacks in patients with acute coronary syndrome who are managed with percutaneous coronary intervention. However, it also seems to present a higher risk of causing internal bleeding, a classic trade-off with blood thinners.

 

To be more specific, for every 24 serious heart problems prasugrel prevented, it caused 10 bleeding side effects. But, the drug was associated with three fewer heart-related deaths than blood thinner Plavix made by Bristol-Myers Squibb. Plavix is the world’s second best-selling drug with more than $7 billion in 2007 global sales.

 

“I think it’s been demonstrated to be safe and effective in an appropriately-selected group of patients,” said panelist Michale Domanski, a cardiologist with the national Institutes of health.

 

Eli Lilly and Daiichi are seeking FDA approval to market prasugrel under the brand name Effient for patients having chest pain or a heart attack and undergoing angioplasty to clear an artery.

 

Prasugrel was submitted for approval last January and since then the FDA had twice put off making a decision because the drug’s side effects. However, the new review shows the drug’s benefits clearly outweigh its risk.

 

Now the FDA will make its own decision, although it is not required to follow the advice of the advisory panel.