Alkem Laboratories Gets CDSCO Panel Nod To study Semaglutide tablet for Type 2 Diabetes Mellitus
New Delhi: Alkem Laboratories has got the go ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalance (BE) study and Phase III clinical trial of Semaglutide Tablets 3mg, 7mg & 14mg (Synthetic origin) for Type 2 Diabetes Mellitus.
However, in line with the above approval, the expert panel opined that the firm should submit BE Study report to CDSCO and BE report should be evaluated from the committee before initiation of Phase-III clinical trial.
This came after Alkem Laboratories presented BE study protocol vide no. BIOS/2024/128, Version No. 01, Dated 17.07.2024 and Phase III CT study protocol vide no. ALK40/SEM3 Version No. 1.0, dated 16.08.2024 for Type 2 Diabetes Mellitus before the Committee.
Semaglutide belongs to a class of medications known as glucagon-like peptide-1 receptor agonists, or GLP-1 RAs. It mimics the GLP-1 hormone, released in the gut in response to eating.
Semaglutide injection is used to treat type 2 diabetes. It is used together with diet and exercise to help control blood sugar. This medicine is also used to lower the risk of heart attack, stroke, or death in patients with type 2 diabetes, obesity, and heart or blood vessel disease.
Semaglutide improves the efficiency of incretin function by activating GLP-1 receptors. It acts by numerous mechanisms, like augmented insulin secretion (glucose-dependent), inhibition of glucagon release and suppressed hepatic gluconeogenesis, thereby reducing both fasting and postprandial glucose.
At the recent SEC meeting for endocrinology and metabolism held on 6th February 2025, the expert panel reviewed BE study protocol vide no. BIOS/2024/128, Version No. 01, Dated 17.07.2024 and Phase III CT study protocol vide no. ALK40/SEM3 Version No. 1.0, dated 16.08.2024 for Type 2 Diabetes Mellitus before the Committee.
After detailed deliberation, the Committee recommended the grant of permission to conduct the BE study and Phase III clinical trial with the following changes in the CT protocol:
1.Retinal examination (fundoscopy) shall be done periodically.2. Rescue criteria and medication need to be defined in the protocol.
Furthermore, the expert panel suggested that the firm should submit BE Study report to CDSCO and BE report should be evaluated from the committee before initiation of Phase-III clinical trial.
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