Dr. Reddy's Labs Gets CDSCO Panel Nod to Manufacture, Market Semaglutide Injection

Semaglutide Injection 2 mg/1.5 mL (1.34 mg/mL), 4 mg/3 mL (1.34 mg/mL), and 8 mg/3 mL (2.68 mg/mL) of synthetic origin have been approved for the treatment of adults with insufficiently controlled Type 2 Diabetes Mellitus as an adjunct to diet and exercise.

It may be used as monotherapy in patients for whom metformin is considered inappropriate due to intolerance or contraindications, or in combination with other medicinal products used for the treatment of diabetes.

The approval is subject to the submission of Post-Marketing Surveillance (PMS) and Periodic Safety Update Report (PSUR) data in accordance with the New Drugs and Clinical Trials (NDCT) Rules, 2019.

This came after the drug major Dr. Reddy's Labs presented the Phase III CT study report of Semaglutide Injection 2 mg/1.5 mL (1.34 mg/mL), 4 mg/3 mL (1.34 mg/mL) and 8 mg/3 mL (2.68 mg/ml) (Synthetic Origin) for Type 2 Diabetes Mellitus before the Committee.

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.

At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the Phase III CT study report of Semaglutide Injection 2 mg/1.5 mL (1.34 mg/mL), 4 mg/3 mL (1.34 mg/mL) and 8 mg/3 mL (2.68 mg/ml) (Synthetic Origin) for Type 2 Diabetes Mellitus presented by Dr. Reddy's Labs.

After detailed deliberation, the committee accepted the Phase III CT study report and recommended the grant of permission for the manufacture and marketing of Semaglutide Injection 2 mg/1.5 mL (1.34 mg/mL), 4 mg/3 mL (1.34 mg/mL) and 8 mg/3 mL (2.68 mg/ml) (Synthetic Origin) for the following indication, with the condition of submission of PMS/PSUR data as per the NDCT Rules, 2019.

Indication:

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise

 as monotherapy, when metformin is considered inappropriate due to intolerance or contraindications.

 in addition to other medicinal products for the treatment of diabetes.