Dr. Reddy proposal to market antidiabetic FDC of Imeglimin and Vildagliptin rejected by CDSCO Panel

This came in line with the proposal presented by drug maker Dr. Reddy's for the grant of permission to manufacture and market FDC of imeglimin HCL and vildagliptin tablets, 1000mg/50mg alongwith bioequivalence (BE) and a Phase III clinical trial, before the committee.

Vildagliptin (LAF237) 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.

Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) are incretin hormones that regulate blood glucose levels and maintain glucose homeostasis. It is estimated that the activities of GLP-1 and GIP contribute more than 70% to the insulin response to an oral glucose challenge. They stimulate insulin secretion in a glucose-dependent manner via G-protein-coupled GIP and GLP-1 receptor signalling.

Vildagliptin exerts its blood glucose-lowering effects by selectively inhibiting dipeptidyl peptidase-4 (DPP-4), an enzyme that rapidly truncates and inactivates GLP-1 and GIP upon their release from the intestinal cells.

Imeglimin HCL class of anti-diabetic medication. It was approved for use in Japan in June 2021. It is an oxidative phosphorylation blocker that acts to inhibit hepatic gluconeogenesis, increase muscle glucose uptake, and restore normal insulin secretion.

At the recent SEC meeting for Endocrinology and Metabolism held on October 19 and 20, 2022, the expert panel reviewed the proposal presented by drug major Dr. Reddy Laboratories to manufacture and market the FDC of Vildagliptin and Imeglimin 50mg/1000mg along with the BE and Phase III clinical trials.

The expert panel observed that permission to manufacture and market Imeglimin tablets was granted recently, and the clinical experience with Imeglimin is very limited.

After detailed deliberation, the committee did not recommend the conduct of the proposed BE and Phase III clinical trial with FDC of Vildagliptin and Imeglimin 50mg/1000mg.