Glenmark gets CDSCO Panel nod to manufacture,market Lobeglitazone, Metformin antidiabetic FDC
New Delhi: Highlighting the clinical trial results that demonstrate the efficacy and safety of combination treatment of Lobeglitazone and Metformin in Indian patients with Type 2 Diabetes Mellitus, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to drug major Glenmark for manufacturing and marketing the antidiabetic fixed dose combination Lobeglitazone Sulfate 0.5/0.5mg plus Metformin Hydrochloride 500/1000mg extended release (ER) Tablets.
However, this approval is subjected to the condition that the drug should be sold at retail only under the prescription of an endocrinologist or internal medicine specialist. This came after the drug maker Glenmark presented the clinical trial report before the committee in light of an earlier SEC recommendation dated September 9,2022.
Lobeglitazone is an antidiabetic medication from the thiazolidinedione class of drugs. It primarily functions as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells. By activating PPAR-gamma and promoting the binding of insulin at fat cells, lobeglitazone thereby has been shown to reduce blood sugar levels, lower hemoglobain A1C (HbA1C) levels, and improve lipid and liver profiles.
Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. It is also used off-label for insulin resistance in polycystic ovary syndrome(PCOS).Metformin decreases blood glucose levels by decreasing hepatic glucose production (also called gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization.
Earlier, the Medical Dialogues Team had reported that at an earlier SEC meeting for Endocrinology and Metabolism held on September 9th, 2022, after extensive review of the proposal presented by Glenmark to manufacture and market the fixed dose combination (FDC) anti-diabetic drug Lobeglitazone Sulphate 0.5/0.5mg plus Metformin HCL 500/1000mg ER tablets, the expert panel had recommended Glenmark to submit the complete clinical trial report.
In view of the above, at a recent SEC meeting, the drug maker Glenmark presented the clinical trial report of the combination treatment of Lobeglitazone and Metformin in Indian patients with Type 2 Diabetes Mellitus.
The committee observed that the Lobeglitazone Tablets 0.5mg are approved in India and the FDC of Lobeglitazone and Metformin is approved outside India (South Korea since 2015).
Furthermore, the expert panel noted that the clinical trial results demonstrate the efficacy and safety of combination treatment of Lobeglitazone and Metformin in Indian patients with Type 2 Diabetes Mellitus.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Lobeglitazone Sulfate 0.5/0.5mg + Metformin Hydrochloride 500/1000mg ER Tablets for the proposed indication, subject to the condition that the drug should be sold by retail only under the prescription of an endocrinologist or internal medicine specialist.
