Sun Pharma Gets CDSCO Panel Nod to Manufacture, Market Antidiabetic FDC Drug
New Delhi: Pharmaceutical major, Sun Pharma Laboratories has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market the antidiabetic fixed-dose combination drug containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin plus Glimepiride plus Metformin Hydrochloride IP (as extended-release).
This came after Sun Pharma Laboratories presented its proposal along with the Phase III clinical trial report and bioequivalence (BE) study report before the committee.
Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin inhibits the sodium-glucose cotransporter 2(SGLT2) which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose reabsorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.
Glimepiride is a sulfonylurea drug used to treat type 2 diabetes mellitus. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells.
Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.
Metformin decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization.
At the recent SEC meeting for Endocrinology and Metabolism held on the 22nd and 23rd of August 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma along with the phase III clinical trial report and BE study report of antidiabetic fixed-dose combination drug containing Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin plus Glimepiride plus Metformin Hydrochloride IP (as extended-release).
After detailed deliberation, the committee recommended for grant of permission for manufacturing and marketing of the proposed FDC, subject to the condition that the firm should conduct the Phase IV clinical trial.
Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 03 months of approval for review by the committee.
