CDSCO Panel Approves New Indications for Novo Nordisk's Semaglutide, Mandates PMS Study

New Delhi: Recommending to conduct post marketing surveillance (PMS) study in India, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted approval to the drug major Novo Nordisk India for the additional indication of the drug Semaglutide Injection 0.25 mg, 0.5 mg, and 1 mg.

The additional indications stated that Semaglutide injection is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus:

• To reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.

• To reduce the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in adults with type 2 diabetes mellitus and chronic kidney disease.

This came after the drug maker Novo Nordisk India presented the proposal for the grant of approval of additional indications of the drug Semaglutide Injection 0.25 mg, 0.5 mg, and 1 mg based on the data generated from Phase III Global Clinical Trials, where India was part of the study.

Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity. Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017.

Semaglutide works by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose. 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.

At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the proposal presented by drug maker Novo Nordisk for the grant of approval of additional indications of the drug Semaglutide Injection 0.25 mg, 0.5 mg, and 1 mg.

The committee noted that the proposed indication is approved in the USA and the EU.

After detailed deliberation, the committee recommended the grant of approval for the proposed additional indication with a condition to conduct a post-marketing surveillance (PMS) study in India.

In view of the above, the expert panel suggested that the firm shall submit the India-specific PMS protocol to CDSCO within 03 months of the grant of permission for this additional indication.