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EMA reviewing Tredaptive

December 22, 2012 1:33 AM UTC

EMA began a review of Tredaptive from Merck & Co. Inc. (NYSE:MRK) after the pharma said data from the investigator-led Phase III HPS2-THRIVE trial showed the cardiovascular drug plus statin therapy failed to reduce the incidence of cardiovascular events vs. statin therapy alone. Tredaptive also increased the incidence of non-fatal serious adverse events. EMA said its Pharmacovigilance Risk Assessment Committee will evaluate the data and make a recommendation to the agency's CHMP, which will then issue an opinion on any regulatory action. CHMP's recommendation is expected in January. EMA recommended that no new patients start treatment with Tredaptive until the review is completed.

On Thursday, Merck reported top-line data from HPS2-THRIVE and said it no longer plans to seek U.S. regulatory approval for Tredaptive. The pharma also recommended that providers in countries where the cardiovascular drug is approved not start new patients (see BioCentury Extra, Dec. 20). ...