Hetero Labs Gets CDSCO Panel Nod To study Semaglutide Injection for Type 2 Diabetes Mellitus
New Delhi: Hetero Labs has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study and Phase III clinical trial of Semaglutide Injection 2mg/1.5ml and 4mg/3ml (1.34mg/ml) (synthetic origin) for Type 2 Diabetes Mellitus.
In addition, the expert panel opined the firm to modify the protocol by including "Retinal examination (fundoscopy) shall be done periodically."
The committee also recommended to the firm to submit the BE Study report to CDSCO and the BE report should be evaluated by the committee before the initiation of the Phase III clinical trial.
This came after Hetero Labs presented the BE study protocol, vide no. AZBE112405, Version No. 01, Dated 15.11.2024 and the Phase III CT study protocol (Protocol no. HCR/III/SEMADM/10/2024, Version No. 01, dated 02.11.2024) 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 your 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, the expert panel reviewed the BE study protocol vide no. AZBE112405, Version No. 01, Dated 15.11.2024 and Phase III CT study Protocol (Protocol no. HCR/III/SEMADM/10/2024, Version no. 01, dated 02.11.2024) for type 2 diabetes mellitus.
After detailed deliberation, the Committee recommended the grant of permission to conduct the BE study and Phase III clinical trial with the following change in the CT protocol:
ï‚· Retinal examination (fundoscopy) shall be done periodically.
Furthermore, the expert panel suggested that the firm should submit the BE Study report to CDSCO and the BE report should be evaluated by the committee before the initiation of the Phase III clinical trial.
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