The FDA declined to expand the indications of ezetimibe (Zetia) and ezetimibe plus simvastatin (Vytorin) to reduce the risk of cardiovascular events in patients with coronary heart disease, according to a Merck news release.
Merck manufactures and markets both drugs. The company said the FDA sent a complete response letter saying the expanded indication was not approved.
“Merck is reviewing the letter and will determine next steps,” the company said.
The announcement noted that ezetimibe’s effect on cardiovascular morbidity and mortality has not been determined. Meanwhile, the combination of ezetimibe and simvastatin has not been shown to be superior compared with simvastatin alone when it comes to cardiovascular morbidity and mortality.
Merck had filed a supplemental new drug application for ezetimibe and ezetimibe plus simvastatin based on results of IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial). The company claimed the medications reduced the risk of cardiovascular death, nonfatal MI, nonfatal stroke, hospitalization for unstable angina or the need for revascularization in patients with coronary heart disease.
Ezetimibe and ezetimibe plus simvastatin are approved as an adjunct therapy to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B and non-high-density lipoprotein cholesterol in patients with primary hyperlipidemia. Patients taking the medications are expected to also improve their diet.