Consumer advocacy group urges FDA rejection of prasugrel

WASHINGTON A researcher who helped develop a drug designed to reduce heart attacks now wants the Food and Drug Administration to reject it.

Working with the consumer advocacy group Public Citizen, Victor Serebruany has sent a letter to FDA commissioner Margaret Hamburg urging the agency not to approve Eli Lilly & Co.’s and Daiichi Sankyo’s drug prasugrel. Serebruany holds a patent application for the drug and sold commercial licensing rights for it to Lilly.

Serebruany cited “serious flaws” in the TRITON-TIMI 38 phase 3 trial of the drug comparing it to Plavix (clopidogrel), by Sanofi-Aventis and Bristol-Myers Squibb. Serebruany said “incorrect” and “unsafe” doses of prasugrel were given to patients and that the drug may act as a “cancer promoter” because of its antiplatelet activity.

“An earlier clinical study showed that a 10 milligram daily dose of prasugrel was far too potent, and I raised concerns that it might result in an increased bleeding risk,” Serebruany said. “This is exactly what was seen in the TRITON-TIMI 38 study. Considering that bleeding rates grow over time, the effects of this drug could be even worse in real-life scenarios.”

A Lilly spokeswoman told Drug Store News that Serebruany voiced the same concerns as a public speaker at a meeting of the FDA’s Cardiovascular and Renal Drugs Advisory Committee, but that the committee voted unanimously that the FDA should approve the drug.

“In response to Public Citizens letter to the FDA, Daiichi Sankyo Inc. and Eli Lilly & Co. remain confident in the overall benefit-risk profile of prasugrel and stand behind the clinical trial design and results from the TRITON-TIMI 38 clinical trial,” the spokeswoman said. “TRITON-TIMI 38 was a head-to-head trial that the TIMI Study Group at Harvard Medical School designed as well as conducted, and the analysis of the trial was rigorous and met the standards of regulatory authorities.”