New Delhi: The drug major Dr. Reddy's Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a bioequivalence (BE) study of Semaglutide Injection 2mg/1.5ml (1.34mg/ml) and 4mg/3ml (1.34mg/ml) which is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus and also indicated for chronic weight management in adults with general obesity.

This came after the drug major Dr. Reddy's Laboratories presented the bioequivalence protocol and justification for Phase III clinical trial waiver before the committee.

Semaglutide is a glucagon-like peptide 1 receptor agonist used to improve glycemic control in type 2 diabetes mellitus. Furthermore, in June 2021, semaglutide was approved by the FDA for chronic weight management in adults with general obesity or overweight who have at least one weight-related condition, marking semaglutide as the first approved drug for such use since 2014. The use of semaglutide in weight management is also approved by Health Canada and the European Medicines Agency (EMA).

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 the reduction of appetite and food cravings after semaglutide administration.

Earlier, in response to the proposal presented by Dr. Reddy's Laboratories for the manufacture and marketing of synthetically developed Semglutide injection 2mg/1.5ml (1.34mg/ml) PFP and Semglutide injection 4mg/3ml (1.34mg/ml) PFP for already approved indication along with the justification for waiver of BE study and Phase-III clinical trial, the expert panel suggested the firm to conduct bioequivalence study with already approved rDNA product and Phase III Clinical Trial of the applied drug product.

As per the prior SEC suggestion, the company submitted the bioequivalence protocol and rationale for seeking a Phase III clinical trial exemption to the committee.

At the recent SEC meeting for endocrinology and metabolism held on 27th and 29th September 2023, the expert panel reviewed the Bioequivalence protocol and the justification for the Phase III clinical trial waiver of Semaglutide Injection.

After detailed deliberation, the Committee recommended the grant of permission to conduct a bioequivalence study as per protocol presented by the firm.

In addition, the expert panel stated that the Phase-III clinical trial waiver can be considered based on the review of the bioequivalence study report by the SEC committee.

Also Read:Revise Phase III CT protocol of Olokizumab as a single-arm study: CDSCO Panel Tells Dr Reddys



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