FDA delays approval of prasugrel

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The FDA has extended the review period for Daiichi Sankyo and Eli Lilly’s prasugrel new drug application (NDA) based on supplemental information provided during the review period, but the agency did not request additional clinical trials. 

The three month extension allows the FDA time to complete its review. The prasugrel NDA was granted priority review by the FDA in February, and the new action date for prasugrel is September 26. 

The initial NDA, submitted in January, was based upon data from several trials, including the TRITON-TIMI 38 clinical trial presented at AHA Scientific Sessions in November 2007, which evaluated the safety and efficacy of prasugrel compared with clopidogrel (Plavix) in reducing ischemic events such as non-fatal heart attack, non-fatal stroke and cardiovascular death in 13,608 patients.

The proposed indication for prasugrel, an oral antiplatelet agent, is for the treatment of patients with acute coronary syndromes being managed with PCI, according to the Tokyo-based Daiichi and the Indianapolis-based Eli Lilly.

In March, the FDA accepted and designated a Priority Review for the NDA for prasugrel.

Daiichi and Lilly also confirmed that the TRILOGY ACS trial, a large phase III clinical trial to compare the effects of prasugrel against clopidogrel (Plavix/Iscover) in medically managed ACS patients started this month.

If approved, prasugrel would compete against the gold-standard Plavix from Bristol-Myers Squibb and Sanofi-Aventis.

Company officials said that if the drug is approved for marketing in the U.S., the brand name for prasugrel will be Effient.