FDA Action on Prasugrel Delayed Until September
The review period for Eli Lilly and Daiichi Sankyo’s antiplatelet drug prasugrel has been extended to Sept. 26 as the FDA reviews supplemental analyses that were submitted after the original NDA was filed.
The FDA is evaluating the prasugrel NDA under priority review. The proposed indication is to treat patients with acute coronary syndromes (ACS) being managed with percutaneous coronary intervention.
Lilly said it remains confident in the prasugrel data package, and the NDA is probably one of the largest submitted to the FDA. If all the files in the application were printed out, the paper stack would be the height of the Empire State Building, according to the company.
“We will continue to work closely with the FDA throughout the review process and continue discussions to determine if any requirements under the new FDA Amendment Act legislation will apply,” Jennifer Stotka, Lilly vice president of Global Regulatory Affairs, said.
The NDA contains data from the TRITON-TIMI 38 clinical trial, which compared the drug in 13,600 patients with Bristol-Myers Squibb and sanofi-aventis’ blockbuster antiplatelet drug Plavix (clopidogrel bisulfate).
The additional analysis submitted to the agency for the prasugrel NDA was primarily based on the TRITON-TIMI 38 data set, Lilly told DID. The company would not say what type of analysis was submitted.
When compared with Plavix, prasugrel demonstrated a statistically significant 52 percent reduction of stent thrombosis in the TRITON-TIMI 38 study. The study also showed that patients on prasugrel had a 19 percent reduction in the relative risk of ischemic events based on a composite endpoint of nonfatal stroke, nonfatal heart attack or cardiovascular death.