In a unanimous decision this evening, the Cardio Renal Advisory Committee of the FDA voted to approve Prasugrel for patients with Acute Coronary Syndrome. This is a good sign that the FDA is finally approving drugs again. This drug was not without critics, but for a unanimous vote, even the representative from the generally anti-industry Consumers Union gave approval.
This does not mean that the FDA will automatically go with the recommendations of the panel, but that is almost always the case, especially with a positive staff review and a unanimous vote of the Advisory Committee.
This is very good news from the FDA given that they have missed two deadlines on approval for this drug. This may be a signal that with the new Administration, the FDA is back to work.
Because of patient diversity, there is a need for additional anti-platelet drugs and the panel recognized that need.
Links to Articles:
The Associated Press: FDA panel unanimously backs Lilly blood thinner
The New York Times: FDA Panel Approves Lilly Clotting Drug
WebMD: FDA Advisory Panel Votes Unanimously in Favor of Prasugrel