FDA delays decision on Eli Lilly blood clot drug

The FDA did not ask for new clinical trials, but company spokeswoman Tammy Hull would not go into details about talks with the FDA.

"Requests for additional information are common during the FDA's initial review," she said.

Lilly fell 1.4 percent to close at $46.94 Tuesday. Earlier in the session, they hit an annual low of $45.97.

Eli Lilly and Co. and its Japanese partner, Daiichi Sankyo Co., hope to gain approval of the drug prasugrel to treat patients with acute coronary syndromes, such as heart attacks or unstable angina, who are at risk of developing blood clots. If approved, prasugrel would compete against the blockbuster Plavix, made by Bristol-Myers Squibb Co. and Sanofi-Aventis SA.

Lilly and Daiichi Sankyo had submitted a new drug application to the FDA on Dec. 26. The agency then granted the drug a priority review, meaning it would try to make a decision by June 26.

The agency now plans to rule on the application by Sept. 26.

Goldman Sachs analyst James Kelly said he isn't surprised the FDA sought more time to review the drug's application, given the large amount of data from prasugrel's late-stage trial, which included more than 13,000 patients.

In a note to clients late Monday, he said he continues to expect the drug to be approved, with launch in mid-2009.

Deutsche Bank-North America analyst Barbara Ryan also cited the complexity of the data and the need to define both the drug's target population and risk profile.