New Delhi: Pharmaceutical major Akum Pharmaceuticals has received the green signal from the Committee of Subject Matter Experts (SEC) functional under the Central Drug Standards Control Organization (CDSCO) to manufacture and market the Fixed Dose Combination (FDC) of the anti-diabetic medicine Glimepiride plus Lobeglitazone sulphate tablet.
This came after the company presented the FDC Glimepiride plus lobeglitazone sulfate bioequivalence (BE) study report to the committee.
Lobeglitazone is an anti-diabetic drug of the thiazolidinedione class. It primarily functions as an insulin sensitizer by binding and activating peroxisome proliferator-activated receptors (PPARs) gamma in fat cells.
Lobeglitazone acts as an insulin sensitizer by binding and activating peroxisome proliferator-activated receptors (PPARs) gamma in fat cells.
Lobeglitazone is used to help regulate blood sugar in patients with type 2 diabetes. 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 post-market surveillance is ongoing through 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 drug will only help lower blood sugar in people who produce insulin naturally.
Glimepiride is used with diet and exercise, and sometimes with other medicines, to treat type 2 diabetes (a condition in which the body usually does not use insulin and therefore does not cannot control the amount of sugar in the blood).
At the recent SEC meeting on Endocrinology and Metabolism held on 2023-04-20 and 2023-04-21, the expert panel reviewed the BE study report submitted by major pharmaceutical company Akum Pharmaceuticals .
The Committee noted that the company has already conducted the BE study and has reviewed the results of the BE study and the rationale for waiving the Phase III CT study at this stage.
After detailed deliberation, the committee recommended granting the authorization to manufacture and market the product after the authorization was granted to the lead applicant who had already conducted the CT study.
Also read: Center plans to test drugs in government labs before exporting