Akums Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC Drug
New Delhi: The drug major Akum Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market the fixed-dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate Eq. to Dapagliflozin 5mg/5mg/5mg/5mg plus Glimepiride IP 1mg/2mg/1mg/2mg plus Metformin Hydrochloride IP (As ER) 500mg/500mg/1000mg/1000mg film coated bilayered tablet.
However, this approval is subject to the condition that Akum Pharmaceutical conduct an Active Postmarketing study (PMS).
This came after Akum Pharmaceutical presented their proposal along with a bioequivalence (BE) report of the higher strength of the proposed FDC (Dapagliflozin10mg + Glimepiride 2mg + Metformin ER 1000mgtablet) before the committee.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. Dapagliflozin 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).
Glimepiride is a 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. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.
Metformin, classified as a biguanide drug, effectively lowers blood glucose levels by decreasing glucose production in the liver, diminishing intestinal absorption, and enhancing insulin sensitivity. As a result, metformin effectively lowers both basal and postprandial blood glucose levels.
At the recent SEC meeting for Endocrinology and Metabolism held on 24th January 2023, the expert panel reviewed the proposal along with the BE report of higher strength of the FDC Dapagliflozin Propanediol Monohydrate plus Glimepiride plus Metformin Hydrochloride film-coated bilayered tablet.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product after submission of data including dissolution data and justification for BE waiver as per the BE Study guideline with the condition that the firm should conduct Active PMS study.
Accordingly, the expert panel suggested that the firm should submit an active PMS study protocol to CDSCO within 03 months of approval for review by the committee.
