FDA panel unanimously recommends approval of prasugrel

The FDA’s cardiorenal advisory committee has unanimously recommended approval of prasugrel.

According to the Dow Jones news story, the panel said prasugrel should not be used in patients with a history of stroke or in patients undergoing cardiac surgery. The panel recommended that a bleeding warning be included for older patients and underweight patients.

Updated (8:40 PM): CardioBrief has received comments from a number of well known experts in the field:

Harvey White: It’s been disappointing that it has taken so long but this is great news for patients. There are three groups of patients who will benefit most: diabetics, patients with drug eluting stents and patients undergoing primary angioplasty. In diabetics and primary angioplasty there is heightened platelet activation and the greater effectiveness of prasugrel is not accompanied by unacceptable bleeding. The landscape has now changed and the comparator for new trials has now become prasugrel.

Magnus Ohman, lead investigator of the TRILOGY-ACS trial comparing prasugrel to clopidogrel in 10,000 medically managed ACS patients, said that prasugrel was a “major new advance” and that “for the majority of patients the benefits outweigh the risk.”

A Heartwire story reported that Eugene Braunwald told the committee that “the approval and use of prasugrel would prevent 23 000 MIs and 4000 deaths annually at a cost of an additional 2300 major bleeding events.”

You can also read:

The New York Times story.

The Bloomberg News story.

The Associated Press story.

Here is the Lilly press release.

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