Macleods Gets CDSCO Panel Nod to Conduct BE Studies for Semaglutide Prefilled Pens

The committee reviewed data for Semaglutide Injection pre-filled pens in multiple strengths, including 0.25 mg, 0.5 mg and 1 mg pre-filled pens (4 mg/3 ml), 2.0 mg pre-filled pens (8 mg/3 ml), as well as higher-dose presentations of 1.7 mg and 2.4 mg (9.6 mg/3 ml). The products are of synthetic origin.

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 deliberations, the committee recommended accepting the presented toxicity data and recommended granting permission for the conduct of the BE study as per the protocol presented by the firm.

Further, the expert panel suggested that the BE report shall be submitted to CDSCO for further review by the committee and consideration of the CT study.