Generate safety and efficacy data: CDSCO Tells Glenmark Over Glimipride, Lobeglitazone FDC
New Delhi: In response to the proposal presented by the drug major Glenmark Pharmaceuticals to conduct the Phase IV clinical trial of the fixed-dose combination of the antidiabetic drug Lobeglitazone sulphate plus Glimepiride, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to generate sufficient safety and efficacy data of the proposed FDC and to submit the Phase IV clinical trial protocol as per the conditions of market authorization.
This came after the firm presented its proposal for waiver of the Phase IV clinical trial before the committee.
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.
Lobeglitazone acts as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells.
Lobeglitazone is used to assist 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 progressing until 2019.
At the recent SEC meeting Endocrinology & Metabolism held on 19th and 20th October 2023, the expert panel reviewed the proposal for waiver of the Phase IV clinical trial of the FDC antidiabetic drug Lobeglitazone sulphate plus Glimepiride.
After detailed deliberation, the committee opined this is a new combination that is the first time introduced in the country. Therefore, it is required to generate sufficient safety and efficacy data. Hence, the firm should submit the Phase IV clinical trial protocol as per the conditions of market authorization before the committee for further review.
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