FDA greenlights prasugrel, after one-year delay

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The FDA this afternoon approved Daiichi Sankyo and Eli Lilly's Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events, including stent thrombosis, in patients with acute coronary syndromes who are managed with PCI.

Based on its new regulatory indications, Effient should be initiated with a loading dose of 60 mg followed by a maintenance dose of 10 mg once daily. In addition, for those patients who weigh less than 132 pounds (60 kg), physicians should consider lowering the maintenance dose to 5 mg once daily, according to the Parsippany, N.J.-based Daiichi and Indianapolis-based Lilly. Patients taking Effient should also take 75 mg to 325 mg aspirin orally once daily, according to their doctors' instructions.

Also, the drug's labeling will include a boxed warning, alerting physicians that the drug can cause significant, sometimes fatal, bleeding. The drug should not be used in patients with active pathological bleeding, a history of transient ischemic attacks or stroke, or urgent need for surgery, including CABG.

In June 2008, the FDA extended its review of the blood-thinning drug until September, at which time the agency prolonged the review indefinitely. On Feb. 4, an FDA advisory panel voted 9 to 0 to recommend prasugrel, which could potentially replace the blockbuster and current gold-standard clopidogrel (Plavix, Bristol Myers Squibb and Sanofi-Aventis). Plavix had sales of about $4.9 billion last year.

Effient was studied in a 13,608-patient TRITON-TIMI trial comparing it to the blood-thinning drug, Plavix, in patients with a threatened MI or an actual MI who were about to undergo angioplasty, according to the FDA. The fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in patients who received Plavix to 7 percent in patients who received Effient. While the numbers of deaths and strokes were similar with both drugs, patients with a history of stroke were more likely to have another stroke while taking Effient, according to the agency.

"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," said John Jenkins, MD, 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."

Daiichi Sankyo and Eli Lilly co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner Ube Industries, received its European approval in February.