Alkem Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug
New Delhi: The drug major Alkem Laboratories has got the green signal from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence study (BE) and Phase III clinical trial of the antidiabetic fixed-dose combination (FDC) Metformin Hydrochloride (As Sustained Release) plus Vildagliptin (as immediate release) plus Glimepiride (as immediate release) (500mg 1000mg+50mg/50 mg+1mg/1mg) Oral/Tablet.
This came after the firm presented the proposal before the committee along with BE study & Phase III clinical trial protocol of FDC Metformin Hydrochloride (As Sustained Release) plus Vildagliptin (as immediate release) plus Glimepiride (as immediate release) (500mg 1000mg+50mg/50 mg+1mg/1mg) Oral/Tablet.
Metformin is an FDA-approved antidiabetic agent that manages high blood sugar levels in type 2 diabetes patients. It reduces glucose absorption from the intestines, lowers liver glucose production, and improves insulin sensitivity. Metformin is recommended with dietary changes and exercise for better results.
Managing blood sugar levels with medications like metformin can prevent complications such as kidney damage, nerve issues, blindness, amputations, and sexual dysfunction. Effective diabetes control can also lower the risk of heart attacks or strokes.
Vildagliptin is an anti-diabetic medication. It works by increasing the release of insulin from the pancreas and decreasing the hormones that raise blood sugar levels. This reduces fasting and postmeal sugar levels.
Glimepiride is a medication used in the management and treatment of type 2 diabetes mellitus. It is in the sulfonylurea class of drugs. This activity outlines the indications, mechanism of action, and contraindications for glimepiride as a valuable agent in managing type 2 diabetes mellitus.
At the recent SEC meeting for Endocrinology and Metabolism held on 18th and 19th May of 2023, the expert panel reviewed the proposal presented by Alkem Laboratories to conduct the study of the FDC Metformin Hydrochloride (As Sustained Release) plus Vildagliptin (as immediate release) plus Glimepiride (as immediate release) (500mg/1000mg+50mg/50 mg+1mg/1mg) Oral/Tablet.
After detailed deliberation, the committee recommended the conduct of the BE study and Phase III clinical trial.
In addition, the expert panel suggested that the result of the BE study should be presented for review by the SEC before the initiation of the clinical trial.
Also Read:Alkem Gets CDSCO Panel Nod To Manufacture, Market Linagliptin, Dapagliflozin antidiabetic FDC
