Sun Pharma Labs gets CDSCO Panel nod to study synthetic-origin Semaglutide solution for injection
New Delhi: Responding to the proposal for granting permission to manufacture and market semaglutide solution for injection (synthetic origin), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to the drug major Sun Pharma Labs to conduct a bioequivalence study and phase III clinical trial of Semaglutide solution for injection (synthetic origin) 2mg/1.5ml, 4mg/3ml, 8mg/3ml.
This came after Sun Pharma Labs presented their proposal for a grant of permission to manufacture and market of Semaglutide solution for injection (Synthetic origin) (2mg/1.5ml) 1.34mg/ml, (4mg/3ml)1.34mg/ml, (8mg/3ml) 2.68mg/ml) along with the Phase III clinical trial and bioequivalence study protocol before the Committee.
Sun Pharma Labs has requested approval to manufacture and market semaglutide solutions for injection for the following indications:
1. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.2. To reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease.
Semaglutide is a glucagon-like peptide 1 (GLP-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.
In hypercholesterolemia, semaglutide is believed to reduce the progression of atherosclerosis via decreased gut permeability and decreased inflammation. Weight loss is believed to occur via a reduction in appetite and food cravings after semaglutide administration.
At the recent SEC meeting for endocrinology and metabolism held on May 16, 2024, the expert panel reviewed the proposal presented by Sun Pharma Labs for a grant of permission to manufacture and market semaglutide solution for injection (synthetic origin).
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