Eris Lifscience Gets CDSCO Panel Nod To Manufacture, Market Antidiabetic FDC

New Delhi: Reviewing the bioequivalence (BE) study report of the fixed-dose combination (FDC) antidiabetic drug Dapagliflozin Propanediol Monohydrate plus Gliclazide plus Metformin Hydrochloride film-coated bilayer tablet, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Eris Lifesciences to manufacture and market the proposed antidiabetic drug.

However, this approval is subject to the condition of conducting the Phase IV clinical trial of the proposed FDC.

This nod came after the firm presented a BE study report of Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin 10mg/10mg + Gliclazide IP (SR) 30mg/60mg + Metformin Hydrochloride IP (SR) 500mg/500mg film-coated bilayered tablet before the committee.

Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin is indicated as an adjunct treatment, alongside diet and exercise, to improve glycemic control in patients ≥10 years of age with type 2 diabetes mellitus.

For patients with chronic kidney disease at risk of progression, dapagliflozin is used to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure.

Dapagliflozin is also indicated to either reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors. Combination products with dapagliflozin also exist, either as a dapagliflozin-saxagliptin or dapagliflozin-metformin hydrochloride formulation.

Gliclazide is a sulfonylurea used to treat hyperglycemia in patients with type 2 diabetes mellitus. Gliclazide is an oral antihyperglycemic agent used for the treatment of non-insulin-dependent diabetes mellitus (NIDDM).

Gliclazide binds to the β cell sulfonylurea receptor (SUR1). This binding subsequently blocks the ATP-sensitive potassium channels. The binding results in the closure of the channels and leads to a decrease in potassium efflux, which leads to depolarization of the β cells.

Metformin is in a class of drugs called biguanides. Metformin helps to control the amount of glucose (sugar) in your blood. It decreases the amount of glucose you absorb from your food and the amount of glucose made by the liver.

Metformin's mechanism of action is the alteration of the energy metabolism of the cell. Metformin exerts its prevailing, glucose-lowering effect by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.

At the recent SEC meeting for Endocrinology and Metabolism held on September 19, 2024, the expert panel reviewed the BE study of the FDC antidiabetic drug Dapagliflozin Propanediol Monohydrate plus Gliclazide plus Metformin Hydrochloride film-coated bilayered tablet

After detailed deliberation, the committee considered the BE study report and recommended the grant of permission to manufacture and market the FDC with the condition of conducting the Phase IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months from approval of the FDC, for further review by the SEC.

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