Abbott's Vildagliptin SR Secures CDSCO Panel Nod on Post-Marketing Safety Data
New Delhi: Abbott Healthcare has received a positive regulatory outcome after presenting the Active Post-Marketing Surveillance (PMS) study report for its Vildagliptin Sustained Release (SR) Tablets 100 mg before the competent committee.
This came after the firm presented the Active Post-Marketing Surveillance (PMS) study report for Vildagliptin 100mg SR Tablets in Type 2 Diabetes Mellitus (T2DM) Patients before the committee.
An Active Post-Marketing Surveillance (PMS) study is a planned, systematic study conducted after a drug has been approved and marketed, with the aim of actively monitoring its safety, effectiveness, and tolerability in real-world clinical use.
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 results in improved glycemic control. In clinical trials, vildagliptin has a relatively low risk of hypoglycemia.
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. DPP-4 cleaves oligopeptides after the second amino acid from the N-terminal end. Inhibition of DPP-4 substantially prolongs the half-life of GLP-1 and GIP, increasing the levels of active circulating incretin hormones. The duration of DPP-4 inhibition by vildagliptin is dose-dependent.
Vildagliptin reduces fasting and prandial glucose and HbA1c. It enhances the glucose sensitivity of alpha- and beta-cells and augments glucose-dependent insulin secretion. Fasting and postprandial glucose levels are decreased, and postprandial lipid and lipoprotein metabolism are also improved.
At the recent SEC meeting, the expert panel reviewed the Active Post-Marketing Surveillance (PMS) study report presented by Abbott Healthcare for Vildagliptin 100mg SR Tablets in Type 2 Diabetes Mellitus (T2DM) Patients.
After detailed deliberation, the committee accepted the Active PMS study report.
