FDA approves Eli Lilly & Co.’s blood-thinning drug

ROCKVILLE, Md. The Food and Drug Administration has approved a new blood-thinning drug to prevent heart attacks in patients who undergo angioplasty surgery.

The agency approved Effient (prasugrel), made by Indianapolis-based Eli Lilly & Co. and Tokyo-based Daiichi Sankyo following a 13,608-patient trial comparing it with Sanofi-Aventis’ and Bristol-Myers Squibb’s Plavix (clopidogrel). During the study, the percentage of people who experienced non-fatal heart attacks following angioplasty was 9.1% among those receiving Plavix and 7% among those receiving Effient.

In angioplasty, surgeons use a small balloon to open an artery that has become clogged with plaque, and a wire mesh called a stent is often inserted into the blood vessel to keep the artery open. However, platelets can collect around the area where the surgery takes place, causing clots that can lead to heart attack, stroke and death.

“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 proceture,” said John Jenkins, director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”

The drug will carry a boxed warning, the highest level of warning that an FDA-approved drug can carry, alerting physicians to the risk of potentially fatal bleeding among patients who take Effient.