Alkem Laboratories gets CDSCO panel nod to manufacture, market Dapagliflozin Propanediol Monohydrate, Linagliptin FDC in lower strength

New Delhi: Based on the clinical trial report presented by the drug major Alkem Laboratories of the higher strength of the fixed dose combination drug antidiabetic drug Dapagliflozin Propanediol Monohydrate plus Linagliptin (10 mg/5 mg) tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) recommended to manufacture and market the proposed FDC in lower strength (5mg?5mg).

This came after the firm presented their proposal along with justification for BE study as well as Clinical Trial waiver for lower strength based on their Clinical Trial report of higher strength i.e. Dapagliflozin 10 mg plus Linagliptin 5 mg tablet.

Dapagliflozin is a sodium-glucose co-transporter-2 (SGLT-2) inhibitor and works by removing sugar from the body with the urine. It is on the World Health Organization's List of Essential Medicines.

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.

Linagliptin is a dipeptidyl peptidase-4 inhibitor that works by increasing the production of insulin and decreasing the production of glucagon by the pancreas. Linagliptin was approved for medical use in the United States, Japan, the European Union, Canada, and Australia in 2011.

It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Linagliptin is an antidiabetic medication. It works by increasing the release of insulin from the pancreas and decreasing the hormones that raise blood sugar levels. This reduces the fasting and postmeal sugar levels.

At the recent SEC meeting Endocrinology & Metabolism held on 19th and 20th October 2023, the expert panel reviewed the proposal along with justification for BE study as well as Clinical Trial waiver for lower strength based on their Clinical Trial report of higher strength i.e. Dapagliflozin 10 mg plus Linagliptin 5 mg tablet.

After detailed deliberation, the committee recommended the grant of permission for the manufacturing and marketing of the proposed FDC in lower strength.

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