Akum Gets CDSCO Panel Nod to Study Antidiabetic FDC Drug
New Delhi: The drug major Akum Pharmaceuticals has got the green signal from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct a bioequivalence study (BE) study of the antidiabetic fixed-dose combination tablet containing Metformin HCl IP (As extended-release form), Glimepiride, Lobeglitazone sulfate.
This came after the firm presented its proposal along with BE study protocol along with justification for Phase III clinical trial (CT) waiver.
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 reduces the hepatic production of glucose, decreases the intestinal absorption of glucose, and enhances insulin sensitivity by increasing both peripheral glucose uptake and utilization. In contrast with drugs of the sulfonylurea class, which lead to hyperinsulinemia, the secretion of insulin is unchanged with metformin use.
Glimepiride lowers blood sugar by causing the pancreas to produce insulin (a natural substance needed to break down sugar in the body) and helping the body use insulin efficiently. This medication will only help lower blood sugar in people who produce insulin naturally.
Glimepiride is used along with diet and exercise, and sometimes with other medications, to treat type 2 diabetes (a condition in which the body does not use insulin usually and, therefore, cannot control the amount of sugar in the blood).
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.
Lobeglitazone acts as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells.
Lobeglitazone is used to assist in the regulation of blood glucose levels of diabetes mellitus type 2 patients. It can be used alone or in combination with metformin. Lobeglitazone was approved by the Ministry of Food and Drug Safety (Korea) in 2013, and the postmarketing surveillance is in progress until 2019.
At the recent SEC meeting for Endocrinology and Metabolism held on 20.04.2023 & 21.04.2023, the expert panel reviewed the proposal along with BE study protocol along with justification for Phase III CT waiver presented by the drug major Akum Pharmaceuticals.
After detailed deliberation, the committee recommended the grant of permission to conduct the BE study.
In addition, the expert panel stated that the result of the BE study should be presented before the committee along the Phase III CT protocol.
Also Read:Glenmark gets CDSCO panel nod for Phase III CT of antidiabetic FDC drug
