by Steve Stiles
Rockville, MD - The US FDA has granted the market go-ahead to prasugrel (Effient, Lilly/Daiichi Sankyo), an antiplatelet agent in the same chemical class as clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis), during PCI in the setting of ACS, the agency has announced in a press release [1]. The FDA review of prasugrel's application took about 18 months.
The approval is based primarily on the strength of the TRITON-TIMI 38 trial, which compared prasugrel against clopidogrel in 13 608 patients with moderate- to high-risk unstable angina, ST-segment-elevation MI (STEMI), or non-ST-segment-elevation MI (NSTEMI). Prasugrel was given as a 60-mg loading dose followed by 10-mg/day maintenance, and clopidogrel was given as a 300-mg loading dose plus 75-mg/day maintenance for six to 15 months.
In their announcement of the approval [2], Daiichi Sankyo and Lilly say the drug should be given at the dosage used in the trial. "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. Patients taking Effient should also take 75 mg to 325 mg aspirin orally once daily, according to their doctors' instructions."
As reported by heartwire when the TRITON-TIMI 38 was presented at the AHA 2007 Scientific Sessions, patients who received prasugrel showed a significant 19% reduction in the primary composite end point of cardiovascular death, MI, and stroke in the entire ACS population. The benefit was about the same across the three kinds of ACS.
The FDA's Cardiovascular and Renal Drugs Advisory Committee unanimously recommended the drug's approval in February 2009, as reported at the time by heartwire. During the hearing, most panel members said they felt comfortable supporting a superiority claim for prasugrel over clopidogrel in ACS patients, despite an increased risk of clinically significant bleeding observed with the newer drug in TRITON-TIMI 38.
According to the FDA announcement, prasugrel'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 ministrokes (transient ischemic attacks) or stroke, or urgent need for surgery, including coronary artery bypass graft surgery."
"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 Dr John Jenkins, director of the Office of New Drugs, in the FDA's Center for Drug Evaluation and Research, in the agency's announcement. "Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug."
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