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

However, the approval is subjected to a condition that the drug maker is required to submit Phase IV clinical trial protocol within 3 months from the date of approval.

This came after the firm presented the bioequivalence report of the FDC of Bempedoic acid plus Atorvastatin Calcium to treat hypercholesterolemia.

In addition, the firm also presented the Phase III clinical trial data generated with the concomitant use of Atorvastatin & Bempedoic acid.

Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor. It targets the cholesterol biosynthesis pathway in the liver. Bempedoic acid inhibits the synthesis of cholesterol in the liver, decreasing LDL cholesterol levels. This reduces the development of atherosclerotic plaques that may increase the risk of cardiovascular events. It is a prodrug that requires activation in the liver.

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.