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FDA extends review time for prasugrel to end of September

6/24/2008

TOKYO & INDIANAPOLIS The Food and Drug Administration has extended the review period for Eli Lilly’s and Daiichi Sankyo’s jointly developed drug anti-platelet prasugrel, the companies said Tuesday in a joint statement.

The FDA gave the companies’ application priority review in February, and the three-month extension will give it more time to complete its review, with a new action date of Sept. 26.

The companies intend for prasugrel to treat patients with acute coronary syndromes being managed with percutaneous coronary intervention, a procedure that opens arteries.

They also announced that a phase III study called TRILOGY ACS to compare the effects of prasugrel to clopidogrel bisulfate in patients with acute coronary syndromes.

“The initiation of the TRILOGY ACS trial demonstrates our continued commitment to investigate prasugrel as a potential therapy for ACS patients who are medically managed,” said John Alexander, Daiichi Sankyo’s global head of research and development.

Clopidogrel bisulfate, marketed by Bristol-Myers Squibb and Sanofi Aventis under the brand name Plavix, had sales of $4.76 billion in 2007, according to Bristol-Myers Squibb financial data.

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