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The Central Drugs Standard Control Organization (CDSCO) Subject Expert Committee has granted approval to Novo Nordisk India for new indications of its Semaglutide injection (0.25 mg, 0.5 mg, and 1 mg). This approval allows Semaglutide to be used as an adjunct to diet and exercise in adults with type 2 diabetes mellitus for:
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Reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
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Lowering the risk of sustained decline in eGFR, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.
The decision follows the review of Phase III global clinical trial data, which included Indian participants. The committee pointed out that these indications are already approved in the USA and the EU.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that helps manage type 2 diabetes by stimulating insulin secretion and reducing blood glucose. It achieves glycemic control by slowing gastric emptying, stimulating pancreatic islet cells, and lowering postprandial glucagon secretion.
As a condition for this expanded approval, Novo Nordisk India must submit a protocol for an India-specific post-marketing surveillance (PMS) study to the CDSCO within three months of permission, ensuring continued monitoring of safety and efficacy in the Indian population.
Disclaimer: This article is for informational purposes only and should not be construed as medical advice. For diagnosis and treatment, always consult a qualified healthcare professional. Regulatory updates and clinical guidelines may change; consult the CDSCO or healthcare authorities for the most current information.
