Exemed Pharma's Empagliflozin-Vildagliptin Combo Rejected by CDSCO Panel Over Questionable Clinical Use

The expert panel noted that while Empagliflozin can be used in patients with varying degrees of renal impairment, Vildagliptin is contraindicated in such cases, thereby rendering the clinical utility of the combination questionable.

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.

By inhibiting DPP-4, vildagliptin prevents the degradation of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which are incretin hormones that promote insulin secretion and regulate blood glucose levels. Elevated levels of GLP-1 and GIP consequently result in improved glycemic control. In clinical trials, vildagliptin has a relatively low risk of hypoglycemia.

At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the proposal, along with the bioequivalence (BE) study report and Phase III clinical trial protocol for Empagliflozin 10 mg/25 mg plus Vildagliptin IP (SR) 100 mg/100 mg tablet.

After detailed deliberation, the committee did not recommend the Phase III clinical trial, noting that while Empagliflozin can be used in patients with varying degrees of renal impairment, Vildagliptin is contraindicated in such cases, thereby rendering the clinical utility of the combination questionable.

In view of the above, the committee did not consider the proposed FDC.