Exemed Pharmaceutical Gets CDSCO Panel Nod to Study Empagliflozin plus Glimepiride plus Metformin FDC
New Delhi: Exemed Pharmaceutical has got approval from the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the bioequivalence (BE) study of the fixed dose combination (FDC) Empagliflozin 12.5mg/12.5mg/12.5mg/12.5mg) plus Glimepiride (1mg/1mg/2mg/2mg) plus Metformin HCl (ER) (500mg/1000mg/500mg/1000mg) film coated bilayered tablet.
This came after Exemed Pharmaceutical presented the proposal before the committee along with BE study protocol.
Empagliflozin is a sodium-glucose co-transporter (SGLT-2) class of medication for diabetes.Empagliflozin is used to treat type 2 diabetes. It works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Empagliflozin does not help patients who have insulin-dependent or type 1 diabetes.
Empagliflozin works by inhibiting the sodium-glucose co-transporter-2 (SGLT-2) found in the proximal tubules in the kidneys. Through SGLT2 inhibition, empagliflozin reduces renal reabsorption of glucose and increases urinary excretion of glucose.
Glimepiride is a medication used in the management and treatment of type 2 diabetes mellitus. It is in the sulfonylurea class of drugs. Glimepiride is used to treat high blood sugar levels caused by type 2 diabetes. It may be used alone, or in combination with insulin or another oral medicine such as metformin. In type 2 diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly.
Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer", leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.
At the recent SEC meeting for Endocrinology and Metabolism held on 7th March 2024, the expert panel reviewed a proposal presented by Exemed Pharmaceutical along with the BE study protocol.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study.
Furthermore, the expert panel stated that the result of the study should be presented before the committee for review along with Phase III clinical trial protocol.
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