Currently Approved Ezetimibe is Denied Additional Claim by FDA

Posted by on December 15, 2015

Yesterday, the Endocrinologic and Metabolic Drug Advisory Committee (EMDAC) convened to discuss ezetimibe (Zetia), which is currently approved for lowering LDL cholesterol levels. Merck/Schering-Plough sought to expand the use of ezetimibe with the additional claim that by adding ezetimibe to statin therapy, acute coronary syndrome (ACS) patients could reduce their risk of cardiovascular events. However, the Agency ruled that new data was not sufficient to expand the drug’s indication.

During the Advisory Committee meeting, the panel voted that the safety and efficacy data from a large morbidity and mortality trial, IMPROVE-IT, did not support the expanded indication for cardiovascular event reduction (5 yes, 10 no, 0 abstentions). 

The vote relied primarily on the results from the IMPROVE- IT trail, which was an 18,000- patient study. IMPROVE-IT showed that over the course of a 7 year follow-up, adding ezetimibe to simvastatin significantly reduced cardiovascular death, MI, unstable angina requiring rehospitalization, coronary revascularization and stroke by 6.4% when compared to patients who received simvastatin alone.

The Agency expressed their doubt in justifying the expanded indication. “There was a weak and not particularly robust effect,” stated Dr. Susan R Heckbert (University of Washington, Seattle). Nevertheless, Panel chair Dr. Robert J Smith (Brown University, Providence, RI) noted that this vote was particularly difficult. “I do think this is a positive, albeit modest, trial. I don’t think it communicates that this drug is not effective in lowering risk; I suspect that it is effective. However, we just don’t know that yet,” said Dr. Smith.

The agency is not obligated to follow its panel’s recommendation, but normally does so. 

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