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12:00 AM
Feb 09, 2009
 |  BioCentury  |  Regulation

Superior data make Effient easy

By coming to last week's FDA panel meeting armed with superior data from a large head-to-head study against the standard of care in acute coronary syndromes, plus rodent data to address a faint cancer signal, Eli Lilly and Co. and Daiichi Sankyo Co. Ltd. made it easy for an FDA panel to recommend approval of their Effient prasugrel. Despite an increase in bleeding events for Effient, the Cardiovascular and Renal Drugs Advisory Committee voted 9-0 to recommend approval of the antiplatelet agent.

The endorsement was based largely on data from the Phase III TRITON-TIMI 38 trial in 13,608 patients with acute ACS scheduled to undergo percutaneous coronary intervention (PCI). Effient was superior to Plavix clopidogrel from Bristol-Myers Squibb Co. and sanofi-aventis Group on the composite primary endpoint of cardiovascular death, nonfatal myocardial infarction (MI) and nonfatal stroke.

The large size of the trial gave clear numbers, impressing the panel and enabling a straightforward risk-benefit analysis. Per 1,000 ACS patients treated, Effient prevented 21 MIs and 3 cardiovascular deaths, while causing 2 fatal hemorrhages, 3 major bleeds and 5 minor bleeds (see "Effient Event Profile," A8).

"The data overwhelmingly supported approval, meaning that the drug showed superiority to clopidogrel and had a favorable efficacy effect that was not outweighed by the adverse events," Marvin Konstam, acting chair of the committee and chief physician executive at The Cardiovascular Center at Tufts Medical Center, told BioCentury after the meeting.

Konstam did caution "that the excess bleeding is a serious issue, and the risk-benefit ratio should be carefully weighed by each physician."

Lilly is seeking approval of Effient to reduce cardiovascular events in patients with ACS who either have unstable angina or non-ST-segment elevation MI and are managed with PCI, or have ST-segment elevation MI when managed with primary or delayed PCI.

The proposed indication does not apply to patients with ACS who are medically managed. But according to Konstam, the majority of patients presenting with ACS now undergo PCI.

Besides giving the panel comfort with their recommendation, TRITON may also influence prescribing habits if Effient is approved.

"If one of my family members was experiencing an acute coronary syndrome and...

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