Alkem Laboratories Gets CDSCO Panel Nod To Study Semaglutide solution for injection
New Delhi: Citing that the retinal examination (fundoscopy) shall be done periodically, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to the drug major Alkem Laboratories for conducting a Phase III clinical trial of semaglutide solution for injection 0.25mg {(1mg /1.5ml)(0.68 mg/ml)}, 0.5mg{(2mg/1.5ml) (1.34mg/ml)}, 1mg {(4mg/3ml)(1.34 mg/ml)}, 1.7mg{(6.8mg/3ml) (2.27mg/ml)} and 2.4mg{(9.6mg/3ml) (3.2mg/ml) (Synthetic origin).
This came after the firm presented the bioequivalence (BE) study waiver based on an earlier BE study report compared with Ozempic (RLD) and Phase-III CT (Protocol no. ALK39-SEM2, Version 1.0, Dated 23/Jul/2024) for weight management 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.
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