Exemed Pharma's Empagliflozin-Vildagliptin Combo Rejected by CDSCO Panel Over Questionable Clinical Use
New Delhi: In a setback to Exemed Pharmaceuticals, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) has declined the proposed fixed-dose combination (FDC) of Empagliflozin (10 mg/25 mg) and Vildagliptin (SR 100 mg/100 mg), citing that the clinical utility of the combination is questionable.
This came after Exemed Pharmaceuticals presented 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, before the committee.
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.
Also Read: Exemed's Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit
Vildagliptin is a once-daily dipeptidyl peptidase 4 (DPP-4) inhibitor used in the management of type 2 diabetes mellitus.Vildagliptin is an orally active antihyperglycemic agent that selectively inhibits the dipeptidyl peptidase-4 (DPP-4) enzyme. It is used to manage type II diabetes mellitus, where GLP-1 secretion and insulinotropic effects are impaired.
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.
