This nod is subjected to the condition that the firm should include Glomerular Filtration Rate (GFR) in the study.
This came in line with the bioequivalance (BE) study protocol in higher strength presented by the drug-maker Akum Pharmaceutical along with the request for a Phase III Clinical Trial study waiver for all proposed strengths before the committee.
On the basis of the presentation made, the committee did not recommend the proposed lower strengths i.e. Bempedoic acid 180mg/180mg/180mg +Rosuvastatin calcium eq. to
Rosuvastatin 5mg/10mg/20mg tablets.
Bempedoic acid is a drug used in conjunction with lifestyle modification and/or other agents for the treatment of refractory hypercholesterolemia.
Bempedoic acid is a prodrug that requires activation in the liver. The very long-chain acyl-CoA synthetase-1 (ACSVL1) enzyme is responsible for its activation to ETC-1002-CoA, the pharmacologically active metabolite. ATP lyase (also known as ATP synthase) plays an important part in cholesterol synthesis. BETC-1002-CoA directly inhibits this enzyme after the parent drug is activated in the liver by coenzyme A (CoA).
This inhibition leads to upregulation of the LDL cholesterol receptor, reducing serum LDL-C via increased uptake and LDL clearance in the liver. By the above mechanisms, bempedoic acid causes a total decrease of circulating LDL-C that normally damages blood vessels and leads to atherosclerosis. Lastly, ETC-1002 activates AMP-activated protein kinase (AMPK) in rodents, which inhibits the synthesis of cholesterol via the inhibition of HMG-CoA reductase. The relevance of this to humans is unknown.
Rosuvastatin is a statin medication and a competitive inhibitor of the enzyme HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase, which catalyzes the conversion of HMG-CoA to mevalonate, an early rate-limiting step in cholesterol biosynthesis. Rosuvastatin acts primarily in the liver, where decreased hepatic cholesterol concentrations stimulate the upregulation of hepatic low density lipoprotein (LDL) receptors which increases hepatic uptake of LDL. Rosuvastatin also inhibits hepatic synthesis of very low density lipoprotein (VLDL). The overall effect is a decrease in plasma LDL and VLDL.
At the recent SEC meeting for Cardiovascular and Renal held on 22.06.2022, the expert panel reviewed the proposal and BE study protocol for Bempedoic acid 180mg/180mg/180mg /180mg+Rosuvastatin calcium eq. to Rosuvastatin 5mg/10mg/20mg/40m g tablets.
After detailed deliberation, the committee recommended for grant of permission to conduct the proposed BE study with the condition to include GFR in the study.
In addition, with regard to the clinical trial study waiver, the committee recommended that the firm should initially present the BE study results before the committee for further consideration of the Phase III CT waiver at that point in time
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