Sun Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug
New Delhi: Pharmaceutical major Sun Pharma 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 fixed-dose combination of the antidiabetic drug Metformin Hydrochloride plus Glimepiride plus Dapagliflozin propanediol monohydrate (500mg/500mg/1000mg/1000mg+1mg/2mg/1mg/2mg+5mg/5mg/5mg/5mg).
This came after the drug major Sun Pharma Laboratories presented its proposal along with the Phase III clinical trial study report and bioequivalence (BE) study report before the committee.
Metformin is an oral anti-diabetic drug in the biguanide class for the treatment of type 2 diabetes mellitus, in particular, in overweight and obese people and those with normal kidney function. Metformin is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. Metformin lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. 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.
Dapagliflozin propanediol monohydrate is a hydrate that consists of dapagliflozin compounded with (S)-propylene glycol and hydrate in a (1:1:1) ratio. It is used to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
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 medication used in the management and treatment of type 2 diabetes mellitus. It is in the sulfonylurea class of drugs. Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone or in combination with insulin or another oral medicine such as metformin. 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.
At the recent SEC meeting for endocrinology and metabolism held on 19th September 2023, the expert panel reviewed the proposal presented by the drug major Sun Pharma Laboratories along with the Phase III clinical trial study report and BE study report of the antidiabetic FDC Metformin Hydrochloride plus Glimepiride plus Dapagliflozin propanediol monohydrate.
After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of the proposed FDC.
