Dr Reddy's gets CDSCO panel nod to manufacture, market lipid-regulating agent Icosapent ethyl capsules
New Delhi: Drug major, Dr Reddy's Laboratories has got a go ahead from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the lipid-regulating agent Icosapent ethyl, used to treat patients with severe hypertriglyceridemia.
However, this approval is subject to a condition that the firm should submit post marketing surveillance (PMS) data to CDSCO after marketing the drug product in the Indian market.
This came after the drug major, Dr Reddy's Laboratories presented their proposal along with some efficacy data of their product marketed in the USA and in-vitro data/comparative data which have been submitted during the approval of their product in the USA before the committee.
Icosapent ethyl is an ethyl ester of eicosapentaenoic acid (EPA) that reduces synthesis and enhances clearance of triglycerides that is used to treat patients with severe hypertriglyceridemia.
Icosapent ethyl is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalizing in adult patients with elevated triglycerides (≥150 mg/dL) and established cardiovascular disease or who have diabetes mellitus and ≥2 other risk factors for cardiovascular disease. It is also indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
EPA reduces hepatic very low-density lipoprotein triglycerides (VLDL-TG) synthesis and secretion and enhances TG clearance from circulating VLDL particles. Potential mechanisms of action include increased β-oxidation; inhibition of acyl-CoA:1,2-diacylglycerol acyltransferase (DGAT); decreased lipogenesis in the liver; and increased plasma lipoprotein lipase activity.
At the recent SEC meeting for Cardiology and Renal held on 27th January 2023, the expert panel reviewed the proposal alongwith some efficacy data of their product marketed in the USA and in-vitro data/comparative data which have been submitted during the approval of their product in the USA.
The committee noted that the drug product is already approved by the United States Food and Drug Administration (USFDA) and available for clinical use in the USA.
After detailed deliberation, the committee recommended the grant of permission for the manufacture and market of the Icosapent Ethyl capsules 1gm for the proposed indication subject to the condition that the firm should submit PMS data to CDSCO after marketing the drug product in the Indian market.
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