Dr. Reddy's gets CDSCO Panel Nod To Study weight loss drug Semaglutide injection

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.

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