Eli Lilly & Co and Daiichi Sankyo announced the U.S. Food and Drug Administration had extended the period of review by three months for their anti-clotting drug, Prasugrel.
Prasugrel received priority review status from the FDA in February based on studies that showed Prasugrel has better results than Plavix but carried a higher risk of bleeding in some patients.
"We remain confident in our prasugrel submission package," said Jennifer Stotka, vice president for global regulatory affairs at Lilly.
Daiichi and Lilly confirmed plans to start a Phase III clinical trial this month that will compare the results of prasugrel against Plavix in patients with acute coronary syndromes. The trials will consisted of 10,000 patients at over 800 hospitals.
The FDA is expected to act on the New Drug Application by Sept 26, 2008.
[Source: CNN]
Comment Preview