BDR Pharma gets CDSCO panel nod to Manufacture, Market Icosapent Ethyl Capsules
New Delhi: The drug maker BDR Pharma has got approval from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the lipid-regulating agent Icosapent Ethyl Capsules 500mg and 1000mg indicated for an adjunct therapy for severe hypertriglyceridemia.
However, this approval is subject to a condition that the firm should submit postmarketing surveillance (PMS) data to CDSCO after marketing the drug product in the Indian market.
This came after the firm presented its proposal for the manufacture and marketing of Icosapent Ethyl Capsules 500mg and 1000mg for the indication “used as an adjunct therapy for severe hypertriglyceridemia (TG levels > 500mg/dl and to reduce the risk of a cardiovascular event in certain patients with elevated triglycerides)” along with bioequivalence (BE) and clinical trial (CT) waiver justification before the committee.
.Icosapent ethyl is an ethyl ester of eicosapentaenoic acid (EPA) that reduces synthesis and enhances clearance of triglycerides that are 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/or 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 the Cardiovascular & Renal held on 27th January 2023, the expert panel reviewed the proposal presented by the drug maker BDR Pharma for the manufacture and marketing of Icosapent Ethyl Capsules 500mg and 1000mg for the indication “used as an adjunct therapy for severe hypertriglyceridemia (TG levels > 500mg/dl and to reduce the risk of a cardiovascular event in certain patients with elevated triglycerides)” along with BE and CT waiver justification before the committee.
The committee noted that the drug product is already approved by 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 applied drug product for the proposed indication subject to condition that the firm should submit PMS data to CDSCO after marketing of the drug product in Indian market.
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