The U.S. Food and Drug Administration said it needs more time to review Eli Lilly and Co.'s prasugrel, this way postponing the launch of a highly anticipated heart drug.

The Indianapolis-based drugmaker and its collaborator Daiichi Sankyo said on Friday that prasugrel will be reviewed in the first quarter of the next year, on Feb. 3, by the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC).

According to J. Anthony Ware, M.D., Lilly vice president and cardiovascular/acute care platform leader for prasugrel, the company relies on the data submitted to the agency and the benefit-risk profile of the potential blockbuster medicine, and is expecting to bring up “an important new alternative to the oral antiplatelet market."

Currently, the blood-clot preventer is under clinical development in conjunction with Eli Lilly and Company for acute coronary syndrome (ACS) planned for percutaneous coronary intervention (PCI). ACS, which represents a set of signs and symptoms related to the heart, affects more than 1.4 million individuals in the U.S. each year.

If approved, prasugrel will compete with Plavix, a medicine developed by Bristol-Meyers Squibb that helps keep blood cells called platelets from sticking together and forming clots, which can help protect against a presumptive stroke or heart attack. The antiplatelet drug Plavix generated global sales of $8.5 billion in 2007.

"I still think this is an approvable drug, but you can't say that with a high degree of confidence given the controversy," asserted Timothy Anderson, a pharmaceutical analyst at Sanford C. Bernstein & Co.