CDSCO Panel Rejects Pure and Cure's Empagliflozin-Based FDC, Flags Risk of UTI, Genital Mycosis
New Delhi: Citing that there is a concern of the risk of genital mycosis and urinary tract infection (UTI) with Empagliflozin, the Subject Expert Committee (SEC), functioning under the Central Drugs Standard Control Organisation (CDSCO), has rejected Pure and Cure Healthcare's proposed Fixed-Dose Combination (FDC) containing Metformin Hydrochloride (extended release), Glimepiride, and Empagliflozin.
This came after Pure and Cure Healthcare presented the proposal along with the bioequivalence (BE) study report and Phase III clinical trial protocol for Fixed-Dose Combination (FDC) Metformin HCl IP (As extended release) 500mg/1000mg/500mg/1000mg + Glimepiride IP 1mg/1mg/2mg/2mg + Empagliflozin 10mg/10mg/10mg/10mg tablets before the committee.
In line with the Phase III clinical trial protocol, the committee opined that there is a concern about the risk of genital mycosis and UTI with Empagliflozin.
Furthermore, the expert panel noted that the clinical utility of this combination is questionable, especially in cases of stable diabetes.
Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus.
Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. It is commonly described as an "insulin sensitizer," leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.
Glimepiride is a sulfonylurea drug used to treat type 2 diabetes mellitus. Glimepiride works by stimulating the secretion of insulin granules from pancreatic islet beta cells by blocking ATP-sensitive potassium channels (KATP channels) and causing depolarization of the beta cells.
At the recent SEC meeting for Endocrinology and Metabolism, the expert panel reviewed the bioequivalence (BE) study report and Phase III clinical trial protocol for Fixed-Dose Combination (FDC) Metformin HCl IP (As extended release) 500mg/1000mg/500mg/1000mg + Glimepiride IP 1mg/1mg/2mg/2mg + Empagliflozin 10mg/10mg/10mg/10mg tablets.
After detailed deliberation, the committee did not consider the BE study report, as the report is inconclusive and flawed regarding adverse events reported.
Regarding the Phase III clinical trial protocol, the committee opined that there is a concern about the risk of genital mycosis and UTI with Empagliflozin. The clinical utility of this combination is questionable, especially in cases of stable diabetes.
In view of the above, the committee did not consider the proposed FDC.
