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FDA declines new indication for ezetimibe
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Merck announced that the FDA has issued a complete response letter regarding a supplemental new drug application for ezetimibe and ezetimibe/simvastatin for the reduction of risk for CV events in patients with CHD, according to a company press release.
The supplemental new drug application was based on results of the IMPROVE-IT trial, in which simvastatin plus ezetimibe, compared with simvastatin alone, was associated with a 6.4% reduction in CV death, nonfatal MI, nonfatal stroke, unstable angina requiring hospitalization and/or coronary revascularization at least 30 days after randomization. The trial included 18,144 participants.
The complete response letter follows a vote by the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee in December 2015 recommending against approval of the supplemental new drug application. Those who voted against approval cited the small magnitude of benefit demonstrated in IMPROVE-IT and broadness of the claim sought by Merck.
Merck is reviewing the letter and will determine next steps, according to the release.
Ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin) are currently approved by the FDA for reduction of total cholesterol, LDL and other lipid parameters in patients with hyperlipidemia or familial hypercholesterolemia.