Prasugrel approved by the FDA

July 10 by C. Michael Gibson, M.S., M.D. (click here for Dr. Gibson's disclosures)

The Food and Drug Administration announced today that Prasugrel (which will be sold under the name Effient) is now approved for clinical use. The drug's label indicates that the drug is effective in reducing the risk of stroke and heart attack in patients undergoing percutaneous intervention and will carry a black label warning regarding an increased risk of potentially fatal bleeding. A panel convened by the FDA had previously voted 9-0 in a recommendation for approval on February 3rd, 2009.

The FDA's Director of New Drugs, John Jenkins, stated in a press release that "Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure," and that "physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug."

FDA statement also indicated that Prasugrel should be avoided in patients with ongoing, a history of stroke or transient ischemic attacks (TIAs or small temporary-strokes), or an urgent need for surgery, including CABG (coronary artery bypass graft surgery).

Given the potential risk of bleeding, it is notable that there are two approved maintenance doses of Prasugrel: 10 mg which was studied in the Triton TIMI 38 trial, and a reduced dose of 5 mg that may be more suitable in patients at an increased risk of bleeding.

Although concerns had been expressed regarding an excess risk of cancer in the Prasugrel arm, Deputy Director of the Cardiovascular & Renal Products division, Ellis Unger, stated that there is no increase in the relative risk of cancer for prasugrel over clopidogrel if those patients with gastrointestinal bleeding are excluded from the analysis.

The drug is marketed by both Eli Lilly and Daiichi-Sankyo.