Akum Gets CDSCO Panel Nod to Manufacture, Market Glimepiride, Lobeglitazone FDC
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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 manufacture and market the fixed-dose combination (FDC) of the antidiabetic drug Glimepiride plus Lobeglitazone sulfate tablet.
This came after the firm presented the bioequivalence (BE) study report of the FDC Glimepiride plus Lobeglitazone sulfate tablet before the committee.
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.
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).
At the recent SEC meeting for Endocrinology and Metabolism held on 20.04.2023 and 21.04.2023, the expert panel reviewed the BE study report presented by the drug major Akum Pharmaceuticals.
The committee noted that the firm has already conducted the BE study and considered the results of the BE study and the justification for Phase III CT Study waiver at this stage.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market the product after the issuance of permission to the main applicant who had already conducted the CT study.
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