Akums Pharma Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug

This came after the drug major Akums Drugs and Pharmaceuticals presented its proposal along with justification of bioequivalence (BE) and Phase III clinical trial waiver based on BE study already conducted on higher strengths of the proposed FDC, Sitagliptin Phosphate Monohydrate 50mg/50mg I.P. plus Pioglitazone 15mg/15mg plus Metformin HCL 500mg/1000mg Sustained Release Form.

However, this approval is conditional on the firm submitting information, including dissolution information and documentation supporting the BE study waiver in accordance with BE Study Guidelines.

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.

Pioglitazone is a drug used in the management of type 2 diabetes mellitus. Pioglitazone is the third marketed thiazolidinedione group of oral antidiabetics, the first is troglitazone which is no longer available due to hepatotoxicity, and the second is rosiglitazone, still on the market.

Pioglitazone works by making cells more sensitive to insulin, which is used to regulate the level of glucose in the body. Improving insulin sensitivity (or reducing insulin resistance) makes it easier for sugar (glucose) in the blood to get into the cells.

Metformin belongs to a class of drugs called biguanides. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Metformin works by reducing the amount of glucose (sugar) made by your liver decreasing the amount of glucose your body absorbs increasing the effect of insulin on your body Insulin is a hormone that helps your body remove extra sugar from your blood. This lowers your blood sugar levels.

At the recent SEC meeting for Endocrinology and Metabolism held on 15th and 16th June 2023, the expert panel reviewed the proposal presented by Akums Drugs and Pharmaceuticals along with justification of BE and Phase III clinical trial waiver based on BE study already conducted on higher strengths of the proposed FDC.

The committee noted that the FDC in higher strength i.e. FDC of Sitagliptin Phosphate Monohydrate 100mg/100mg plus Pioglitazone 15mg/15mg plus Metformin HCL 500mg/1000mg (SR) is already approved by CDSCO on 20.01.2023.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product after submission of data including the dissolution data and justification of BE study waiver as per the BE Study guideline.

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