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July 10, 2009 -- 1:50pm PDT

Prasugrel / Effient Approved by FDA
Eli LillyAfter a year-and-a-half of review, amid concerns over potentially serious bleeding complications, the FDA today approved Eli Lilly's blood thinner Prasugrel as a drug "to reduce the risk of blood clots from forming in patients who undergo angioplasty" (it will be marketed in the U.S. as Effient). Prasugrel will now be an alternative to Bristol-Myers Squibb's Plavix, although the FDA approval comes with a "black box warning" to physicians to be aware of potentially fatal bleeding complications -- this warning would ostensibly alert physicians to monitor patients carefully. Prasugrel was shown in studies of over 13,000 patients to prevent more heart attacks than Plavix, although there was more internal bleeding.

Drug-eluting stentIt remains to be seen what the availability of prasugrel will mean for stent patients. Currently, patients receiving drug-eluting stents are given Dual AntiPlatelet Therapy (DAPT) which is aspirin for life and Plavix for a year or more. There have been a number of studies regarding the optimum length for DAPT: some have shown no benefit beyond six months, others indicate increased benefit and protection against late stent thrombosis; one observational study from the VA even noted that that there may be a "Plavix-rebound" effect, a doubling of heart attack or death within 90 days after stopping Plavix. Furthermore, some patients have been shown to be "Plavix-resistant" and, as such, are at higher risk for stent thrombosis. Given the number of sessions at national cardiology meetings on these issues, how prasugrel / Effient fits into post-stent therapy will no doubt be the subject of much debate.

Effient is manufactured by Eli Lilly and Company of Indianapolis, in partnership with Tokyo-based Daiichi Sankyo Ltd.

Late Update: Here's part of the statement from the FDA:

Effient was studied in a 13,608-patient trial comparing it to the blood-thinning drug, Plavix (clopidogrel), in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty.

The fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1 percent in patients who received Plavix to 7.0 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. In addition, there was a greater risk of significant, sometimes fatal bleeding seen in patients who took Effient.

“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, M.D., 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’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 mini-strokes (transient ischemic attacks) or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.

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