Sun Pharma Gets CDSCO panel nod to manufacture, market antidiabetic FDC drug

This came after the company presented the committee with the clinical report (CT) of the FDC Dapagliflozin Propanediol plus Sitagliptin plus Metformin Hydrochloride tablets.

Dapagliflozin Propanediol is the propanediol form of dapagliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys. Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor indicated for managing diabetes mellitus type 2. When combined with diet and exercise in adults, dapagliflozin helps to improve glycemic control by inhibiting glucose reabsorption in the proximal tubule of the nephron and causing glycosuria.

Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (a condition in which blood sugar is too high because the body does not produce or use insulin normally). Sitagliptin increases insulin production and decreases hepatic glucose overproduction. Sitagliptin prolongs the action of GLP-1 and GIP. By enhancing active incretin levels, sitagliptin increases insulin production and lowers glucagon secretion from alpha cells, which decreases hepatic glucose overproduction.

Metformin Hydrochloride is the hydrochloride salt of the biguanide metformin, which has antihyperglycemic and potential antineoplastic activities. Metformin inhibits complex I (NADPH: ubiquinone oxidoreductase) of the mitochondrial respiratory chain, thereby increasing the cellular AMP to ATP ratio and leading to the activation of AMP-activated protein kinase (AMPK) and regulating AMPK-mediated transcription of target genes. This eventually prevents hepatic gluconeogenesis, enhances insulin sensitivity, and promotes fatty acid oxidation, all of which ultimately lead to a decrease in glucose levels.

At an earlier SEC meeting for Endocrinology & Metabolism dated October 26, 2021, regarding the above FDC, the committee had suggested the drug major Sun Pharma for conducting the Phase III CT study, along with the condition that more government sites should be included in the CT study.

In continuation, at the recent SEC meeting for Endocrinology & Metabolism held on February 16–17, 2023, the expert panel reviewed the clinical trial report of the FDC Dapagliflozin Propanediol to Monohydrate, equivalent to Dapagliflozin 5 mg/5 mg plus Sitagliptin 50 mg/50 mg plus Metformin Hydrochloride 500 mg/1000 mg tablets.

After detailed deliberation, the committee recommended granting permission to manufacture and market the FDC, Dapagliflozin Propanediol to Monohydrate, equivalent to Dapagliflozin 5 mg/5 mg plus Sitagliptin 50 mg/50 mg plus Metformin Hydrochloride 500 mg/1000 mg tablets.

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