Dr. Reddy proposal to market antidiabetic FDC of Imeglimin and Vildagliptin rejected by CDSCO Panel - Medical Dialogues
Overview
New Delhi: Noting that the clinical experience with the drug Imeglimin is very limited, the Subject Expert Comite (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has rejected pharma major Dr. Redy's proposal to manufacture and market the anti-diabetic fixed dose combination (FDC) drug Imeglimin HCI plus Vildagliptin Tablets, 10mg/50mg.This came in line with the proposal presented by drug maker Dr.
Key Information
Redy's for the grant of permision to manufacture and market FDC of imeglimin HCL and vildagliptin tablets, 10mg/50mg alongwith bioequivalence (BE) and a Phase I clinical trial, before the comite.Vildagliptin (LAF237) is an oraly active antihyperglycemic agent that selectively inhibits the dipeptidyl peptidase-4 (DP-4) enzyme. It is used to manage type I diabetes melitus, where GLP-1 secretion and insulinotropic efects are impaired.Glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) are incretin hormones that regulate blod 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 chalenge. They stimulate insulin secretion in a glucose-dependent maner via G-protein-coupled GIP and GLP-1 receptor signaling. Vildagliptin exerts its blod glucose-lowering efects by selectively inhibiting dipeptidyl peptidase-4 (DP-4), an enzyme that rapidly truncates and inactivates GLP-1 and GIP upon their release from the intestinal cels.Imeglimin HCL clas of anti-diabetic medication.
Summary
It was aproved 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 meting for Endocrinology and Metabolism held on October 19 and 20, 2022, the expert panel reviewed the proposal presented by drug major Dr. Redy Laboratories to manufacture and market the FDC reflects the growing demand for innovative healthcare solutions. Investment in research and development continues to advance the field, providing patients with improved treatment options and better health outcomes.
Frequently Asked Questions
Diabetes is a metabolic condition where the body cannot properly regulate blood sugar levels. Type 1 results from insufficient insulin production, while Type 2 develops when cells become resistant to insulin. Risk factors include genetics, obesity, sedentary lifestyle, and age.
Common symptoms include excessive thirst, frequent urination, unexplained weight loss, fatigue, blurred vision, and slow-healing wounds. Type 1 symptoms develop rapidly, while Type 2 symptoms may appear gradually. Many people have no symptoms initially, which is why screening is important.
Diagnosis involves blood tests measuring fasting glucose, HbA1c levels, and glucose tolerance. Regular monitoring typically includes fasting glucose tests and HbA1c measurements every 3-6 months. Continuous glucose monitors provide real-time tracking for better diabetes management.
Effective management includes regular physical activity (150+ minutes weekly), maintaining healthy weight, following a balanced diet with whole grains and lean proteins, managing stress, and getting adequate sleep. These changes can significantly improve blood sugar control and reduce complications.
Consult a healthcare provider if you experience signs of diabetes, have a family history, are overweight, or are over 45. Those with existing diabetes should maintain regular check-ups every 3-6 months to monitor control and adjust treatment as needed.
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