Dr. Reddy's Lab gets CDSCO Panel nod to study Semeglutide injection
New Delhi: In line with the bioequivalence study report of Semaglutide Injection 2mg/1.5ml (1.34mg/ml) and 4mg/3ml (1.34mg/ml) (Synthetic Origin) presented by the drug major Dr Reddy's Lab, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to conduct a Phase III clinical trial of Semaglutide Injection as per the protocol presented.
In addition, the expert panel opined that the firm submit the results for further deliberation.
This came after Dr. Reddy's lab presented the bioequivalence study report and the Phase-III clinical trial protocol 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 insulin3 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.
Earlier, at 106 the SEC meeting held on 27.09.2023 and 29.09.2023, the firm had presented Bioequivalence protocol and Justification for Phase-III clinical trial waiver before the committee. Responding to this, the expert panel had stated that Phase-III clinical trial waiver can be considered based on the review of the bioequivalence study report by the SEC committee.
Now in line with the above, at the recent SEC meeting for Endocrinology and Metabolism held on July 24, 2024, the expert panel reviewed the bioequivalence study report along with the Phase-III clinical trial protocol of the Semaglutide Injection presented by the drug major Dr Reddy's Lab.
After detailed deliberation, the committee considered the bioequivalence report and recommended the grant of permission to conduct a phase III clinical trial study as per the protocol presented and further stated to submit the results for further deliberation.
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