The Subject Expert Committee (SEC) under the Central Drug Standard Control Organisation (CDSCO) has granted approval to Eris Lifesciences for the manufacture and marketing of a fixed-dose combination (FDC) antidiabetic drug, Dapagliflozin Propanediol Monohydrate, Gliclazide, and Metformin Hydrochloride film-coated bilayer tablet. This approval follows the firm’s presentation of a bioequivalence (BE) study report to the committee.
As reported by medicaldialogues, however, the approval is contingent upon the company conducting a Phase IV clinical trial. The firm is required to submit the Phase IV clinical trial protocol to CDSCO within three months of approval for further review by the SEC
Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is used as an adjunct to diet and exercise to manage type 2 diabetes mellitus in patients aged 10 and older. It is also prescribed to reduce the risk of kidney disease progression, cardiovascular death, and hospitalization in patients with chronic kidney disease or heart failure. Combination products with dapagliflozin, including those with saxagliptin or metformin hydrochloride, are already available.
Gliclazide, a sulfonylurea, treats hyperglycemia in type 2 diabetes by binding to the β-cell sulfonylurea receptor, which blocks ATP-sensitive potassium channels and stimulates insulin secretion.
Metformin, a biguanide, lowers blood glucose levels by reducing hepatic glucose production and enhancing insulin sensitivity.
At the SEC meeting held on September 19, 2024, the expert panel thoroughly reviewed the BE study report and recommended approval of the FDC, with the condition that the Phase IV clinical trial is conducted.