Justify rationality for FDC Sitagliptin, Lobeglitazon: CDSCO Panel Tells Synokem Pharma
New Delhi: In line with the drug major Synokem pharmaceutical's proposal for deliberation of bioequivalence (BE) and phase III clinical trial protocol of the fixed-dose combination (FDC) Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has opined that the firm should justify rationality for combining this FDC and its significant benefit.
In addition, the expert panel suggested that the firm should explain the justification for the dose titration, international approval status, and the scientific literature available from a peer-reviewed journal in support of combining this FDC.
This came after the firm presented its proposal and requested for deliberation of BE & Phase III CT protocol for Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets.
Sitagliptin is used to control blood sugar levels in patients with type 2 diabetes mellitus. It is used along with diet and exercise to improve blood sugar control in adults with type 2 diabetes. Sitagliptin is an anti-diabetic medication. It works by increasing the release of insulin from the pancreas and decreasing the hormones that raise blood sugar levels. This reduces fasting and postmeal sugar levels.
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. By promoting the binding of insulin at fat cells, lobeglitazone has been shown to reduce blood sugar levels.
At the recent SEC meeting for Endocrinology and Metabolism held on the 20th and 21st of April 2023, the expert panel reviewed the proposal presented by Synokem Pharmaceutical for deliberation of BE & Phase III CT protocol of the FDC Sitagliptin Phosphate monohydrate IP 100mg plus Lobeglitazone sulfate 0.5mg Film-Coated tablets
After detailed deliberation, the committee recommended that the firm should justify on following points before presenting the protocol:
1. Firm should present the justification on rationality for combining this FDC and its significant benefit.
2. Justification on dose titration.
3. International approval status.
4. Scientific literature available from peer-reviewed journals in support of combining this FDC.
Accordingly, the expert panel suggested that the firm should submit the justification to CDSCO for review by SEC.
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