This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryMerck expands population for Zocor (simvastatin) with April 16 approval for use in patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease. The sNDA was based on the five-year, 20,536-patient Heart Protection Study, showing an 18% reduction in risk of death from CHD, a 38% reduction in the risk of non-fatal myocardial infarction, a 25% reduction in the risk of stroke and a reduction in the need for coronary (30%) and non-coronary (16%) revascularization procedures with simvastatin. Safety-related labeling changes were also made, including extended liver function testing beyond the first year of treatment "as clinically indicated
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