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Daiichi Sankyo Co. (9130.TO) of Japan and Eli Lilly & Co. (LLY) said the Food and Drug Administration extended the review period three months for their anti- clotting drug prasugrel.

The FDA is expected to act by Sept. 26.

Lilly's shares were at $47.26, down 0.7%, in after-hours trading - their lowest level in six years.

Prasugrel has the potential to be a blockbuster. Last fall, Daiichi and Lilly presented results showing that prasugrel works better than would-be competitor Plavix but carries a higher risk of bleeding in some patients. Analysts and doctors say prasugrel's use is likely to be limited even if the drug wins quick marketing authorization.

The FDA granted the three-month extension for its new drug application based on supplemental information provided during the review period. The new drug application received priority review from the FDA in February.

"We remain confident in our prasugrel submission package," said Jennifer Stotka, vice president for global regulatory affairs at Lilly.

Daiichi and Lilly also affirmed their plan to start a large Phase III clinical trial this month to compare the effects of prasugrel against Plavix in patients with acute coronary syndromes. The trial will involve about 10,000 patients at more than 800 hospitals in 35 countries.

John Alexander, global head of research and development at Daiichi, said the new trial "demonstrates our continued commitment to investigate prasugrel as a potential therapy for ACS patients who are medically managed."

Acute coronary syndromes, which includes heart attacks and unstable angina, or chest pain, affect more than 1.4 million people in the U.S. each year. About 320,000 people experience recurrent heart attacks annually.

-By Kathy Shwiff

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