FDA panel weighs in on TRITON TIMI outcomes. Image Source: Native Remedies

After much anticipation, an FDA advisory panel today voted 9 to 0 to recommend prasugrel—a blood-thinner that could replace the blockbuster clopidogrel (Plavix, Bristol Myers Squibb and Sanofi-Aventis)—as a treatment for patients with acute coronary syndrome (ACS). The FDA usually, but not always, follows such recommendations.

Prasugrel (to be marketed as Effient), developed collaboratively by the Indianapolis-based Eli Lilly and the Toyko-based Daiichi Sankyo, has been under the pre-approval review process January 2008. The FDA has been delaying its decision since June 2008.

The Wall Street Journal (WSJ) reported that the FDA did not invite the Safety and Risk Management Committee to today's meeting with the Cardiovascular and Renal Drugs panel to discuss the pros and cons of the drug.

An FDA spokeswoman told the WSJ that the agency "feels the Cardiovascular and Renal Drugs Advisory Committee has the appropriate expertise for this discussion.” She added that every drug advisory committee looks at safety as well as efficacy.

In a 357-page review posted online on Jan. 30, the FDA advisory panel wrote that "prasugrel appeared to be superior to established treatment for the prevention of nonfatal MI.” However, it also recommended a restricted use due to bleeding concerns that arose during the TRITON-TIMI trialing.

Specifically, the panel pointed out prasugrel’s benefit, as it was associated with an 18 percent reduction in the hazard ratio for TRITON TIMI’s primary end point in the unstable angina and non-STEMI population, a 19 percent reduction in the all acute coronary syndrome population, and a 21 percent reduction in the STEMI population. Yet, the panel noted that the primary risk was bleeding, which was “clearly worse on prasugrel.”

Also, data revealed 27 cases of cancer in prasugrel patients compared with 19 patients taking Plavix. Regarding this, Lilly’s Vice President J. Anthony Ware, MD, responded that the company has “investigated this issue very carefully, and there's no scientific evidence that prasugrel causes new cancer or makes an existing cancer worse.”

Lilly has already suggested not prescribing the drug for patients with a history of stroke or at a higher risk of bleeding, and said it intends to implement labeling so that patients older than 75 or those weighing less than 132 pounds will be restricted from using the drug.