FDA Approves Effient for ACS
July 10, 2009—Daiichi Sankyo, Inc. (Parsippany, NJ) and Eli Lilly and Company (Indianapolis, IN) announced that the US Food and Drug Administration has approved Effient (prasugrel) tablets for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with acute coronary syndromes (ACS) who are managed with percutaneous coronary intervention (PCI).
Daiichi Sankyo and Eli Lilly codeveloped Effient, which was discovered by Daiichi Sankyo and its research partner, Ube Industries, Ltd. (Tokyo, Japan). The companies noted that Effient should be initiated with a loading dose of 60 mg followed by a maintenance dose of 10 mg once daily. In addition, for patients who weigh < 132 lbs (60 kg), physicians should consider lowering the maintenance dose to 5 mg once daily. Patients taking Effient should also take 75 to 325 mg of aspirin orally once daily, as instructed by their doctors.
According to the companies, the approval was based on results from the pivotal phase 3 TRITON-TIMI 38 clinical trial, which compared Effient with clopidogrel bisulfate (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership, Bridgewater, NJ) in reducing cardiovascular events in 13,608 ACS patients managed with PCI. The study showed that Effient taken with aspirin had a 19% relative risk reduction of the combined endpoint of cardiovascular death, nonfatal heart attack, or nonfatal stroke versus Plavix taken with aspirin. This benefit was driven predominantly by a reduction in heart attacks. The benefit of Effient compared with Plavix was seen as early as 3 days and continued during the 15 months of the trial. In addition, there were fewer incidents of stent thrombosis in patients treated with Effient compared to Plavix, with a relative risk reduction of approximately 50%.
"The data from the TRITON-TIMI 38 phase 3 pivotal trial provide compelling evidence that treatment with prasugrel significantly reduced the combined risk of cardiovascular death, heart attack, or stroke over the current standard of care, clopidogrel, across a wide variety of patient types," commented the trial's lead investigator, Elliott Antman, MD. "Prasugrel is an important new option for patients with ACS who are managed with PCI."
Dr. Antman noted that prasugrel was associated with a significantly higher risk of serious bleeding events compared with clopidogrel, but that appropriate patient selection may help reduce this risk. The risk of bleeding was highest in patients treated with Effient who were 75 years of age or older, weighed < 132 pounds (60 kg), or had a history of transient ischemic attacks or stroke. Effient is contraindicated in patients with a history of transient ischemic attack/stroke. It is generally not recommended in patients 75 years of age or older, except for patients in high-risk situations, such as those with diabetes or a history of heart attack.