Conduct Phase III CT: CDSCO Panel Tells Sun Pharma on Liraglutide solution for injection PFP
New Delhi: Responding to the proposal presented by drug major Sun Pharma, for manufacturing and marketing the antidiabetic drug Liraglutide 6 mg/ml solution for injection in a pre-filled pen (PFP), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined the firm to conduct the Phase III clinical trial of the applied drug Liraglutide 6 mg/ml solution for injection in a pre-filled pen.
This came after the firm presented the proposal for the manufacture and marketing of synthetically developed Liraglutide 6mg/ml solution for injection in PFP (18mg/3ml PFP) for already approved indication along with bioequivalence study report and justification for a waiver of Phase III clinical trial.
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 cyclase. 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.
Liraglutide injection is used with a diet and exercise program to control blood sugar levels in adults and children 10 years of age and older with type 2 diabetes (a condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) when other medications.
At the recent SEC meeting for Endocrinology and Metabolism held on the 20th and 21st of April 2023, the expert panel reviewed the proposal for the manufacture and marketing of synthetically developed Liraglutide 6mg/ml solution for injection in PFP (18mg/3ml PFP) for already approved indication along with bioequivalence study report and justification for the waiver of Phase III clinical trial.
After detailed deliberation, the committee recommended that the firm should conduct a Phase III clinical trial of the applied drug product.
Accordingly, the expert panel stated that the firm should submit the protocol for the Phase III clinical trial for further review by the committee.
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