Exemed Pharmaceutical gets CDSCO panel nod to Manufacture, market FDC Bempedoic Acid plus Atorvastatin Calcium

Atorvastatin is an HMG-CoA reductase inhibitor, which lowers lipid levels and reduces the risk of cardiovascular disease including myocardial infarction and stroke. It inhibits the endogenous production of cholesterol in the liver, lowers abnormal cholesterol and lipid levels, and ultimately reduces the risk of cardiovascular disease. Atorvastatin is indicated for the treatment of several types of dyslipidemias, including primary hyperlipidemia and mixed dyslipidemia in adults.

This fixed dose combination of bempedoic acid combined with lower statin doses, especially of Atorvastatin offers LDL-Cholesterol lowering compared with statin monotherapy at higher doses. The current guidelines recommend the combination of maximally tolerated statins with non-statin agents such as bempedoic acid to intensify LDL-cholesterol lowering in patients who cannot achieve desired LDL-cholesterol goals with maximally tolerated statin therapy alone. In addition to greater efficacy with combined statin and non-statin therapy compared with either therapy alone, this combination also reduces the risk of cardiovascular events.

At the recent SEC meeting for Cardiovascular & Renal held on September 7th, 2022, the expert panel reviewed the bioequivalence report and the Phase III clinical trial data of the FDC of Bempedoic acid plus Atorvastatin Calcium.