CDSCO Panel Reviews Novo Nordisk's PMS Study, Clears Data on Oral Semaglutide

New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) reviewed the Post Marketing Surveillance (PMS) study data submitted by Novo Nordisk India Private Limited for once daily oral semaglutide, a treatment for adults with Type 2 diabetes.

The study, titled “A multicenter, prospective, non-interventional single-arm study investigating clinical parameters associated with the initiation of once-daily oral semaglutide in a real-world adult population with Type-2 diabetes in India” (Study ID: NN9924-4960, version 1.0 dated 08.04.2022).

Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus, treat obesity, and reduce the risk of major adverse cardiovascular events in selected adults.

GLP-1 is a physiological hormone that promotes glycemic control via several different mechanisms, including insulin secretion, slowing gastric emptying, and reducing postprandial glucagon secretion. The homeostasis of glucose is dependent on hormones such as insulin and amylin, which are secreted by the beta cells of the pancreas. Semaglutide is 94% similar to human GLP-1. Analogs of this hormone such as semaglutide stimulate the synthesis of insulin by stimulating pancreatic islet cells and reducing glucagon secretion. They directly bind with selectivity to the GLP-1 receptor, causing various beneficial downstream effects that reduce blood glucose in a glucose-dependent fashion.

After detailed deliberation, the committee noted the adequacy of the results of the Post Marketing Surveillance (PMS) study presented by the firm.