Ensure safety, efficacy of applied Synthetic product: CDSCO panel Tells Sun Pharma for Liraglutide Injection
New Delhi: Rejecting the request presented by drug major Sun Pharma for a clinical trial waiver for glucagon-like peptide-1 analog Liraglutide injection, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has recommended the firm should conduct a Phase III trial to ensure the safety and efficacy of the applied Synthetic product and submit the Phase III clinical trial protocol for review.
This came after the firm presented the proposal for manufacturing and marketing Liraglutide 6mg/ml solution for injection pre-filled pen (PFP) (18mg/3ml PFP) synthetic origin along with pharmacokinetic data along with justification for Phase III clinical trial waiver.
Liraglutide is a GLP-1 analog used in the management of type 2 diabetes mellitus and the prevention of cardiovascular complications associated with diabetes.
Liraglutide is an acylated synthetic glucagon-like peptide-1 analog. Liraglutide is an agonist of the glucagon-like peptide-1 receptor which is coupled to adenylate cyclaseLabel. The increase in cyclic AMP stimulates the glucose-dependent release of insulin, inhibits the glucose-dependent release of glucagon, and slows gastric emptying to increase control of blood sugar.
At the recent SEC meeting for Endocrinology and Metabolism held on 18th July 2023, the expert panel reviewed the proposal presented by drug major Sun Pharma for manufacturing and marketing Liraglutide 6mg/ml solution for injection PFP (18mg/3ml PFP) synthetic origin along with pharmacokinetic data along with justification for Phase III clinical trial waiver.
After detailed deliberation, the committee did not consider the request for a clinical trial waiver.
Accordingly, the committee recommended that the firm conduct a Phase III trial to ensure the safety and efficacy of the applied Synthetic product. Therefore, the firm should submit the Phase III clinical trial protocol for review by the committee.
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