New Delhi: Alkem Laboratories has got the go-ahead from the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) for the manufacture and marketing of Semaglutide Injection in multiple strengths for the treatment of Type 2 Diabetes Mellitus.
The approval is designated 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.
This came after the firm presented Phase III clinical trial study report for Type 2 Diabetes Mellitus before the committee, in the light of earlier SEC recommendations dated 13.01.2025.
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 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 for 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.
