Blood thinner prasugrel, made by Eli Lilly and Co. in a joint with Daiichi Sankyo Co., Ltd., is more effective in preventing heart diseases than any other drug available on the market, the US Food and Drug Administration said on Friday.

 

“Superiority, not to a placebo, but to an active drug…, prasugrel’s efficacy seems beyond question,” an advisory panel revealed on the agency’s Web site, suggesting the drug is ready for approval.

 

The drug 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.

 

According to data reviewed by the FDA panel, 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. Plavix is the world’s second best-selling drug developed by Bristol-Myers Squibb.

 

On the other hand, the data showed 27 cases of cancer in prasugrel patients compared to 19 in Plavix, but this could be due to chance, the panel said, adding that the drug could carry a black box warning if approved.

 

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.

 

On Tuesday, the FDA will make a decision on whether the available data on the drug are strong enough to allow prasugrel to be marketed as a superior treatment.