A panel of experts from the Central Drug Standard Control Organization (CDSCO) has asked Akum Pharma to present the justification and rationality for combining the fixed dose combination (FDC) of Lobeglitazone sulfate and Sitagliptin Phosphate monohydrate.
The panel, which met on June 29, 2023, also asked the company to present justification on dose titration and international approval status for the FDC.
Lobeglitazone is a thiazolidinedione (TZD) that works by increasing the sensitivity of muscle and fat cells to insulin. Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by blocking the breakdown of incretins, which are hormones that help to lower blood sugar levels.
The combination of Lobeglitazone and Sitagliptin has been shown to be effective in lowering blood sugar levels in people with type 2 diabetes. However, the CDSCO panel is asking Akum Pharma to provide more information on the rationale for combining these two drugs in a single FDC.
The panel is also concerned about the dose titration of the FDC. Lobeglitazone is typically started at a low dose and then titrated up as needed. However, the CDSCO panel is asking Akum Pharma to provide more information on how the dose of the FDC should be titrated.
Finally, the panel is asking Akum Pharma to provide information on the international approval status of the FDC. Lobeglitazone and Sitagliptin are both approved by the US Food and Drug Administration (FDA) as separate drugs. However, the FDC of Lobeglitazone and Sitagliptin has not yet been approved by the FDA.
The CDSCO panel will meet again to discuss the FDC of Lobeglitazone and Sitagliptin on July 13, 2023. At that time, Akum Pharma will be expected to provide the requested information.
About the CDSCO
The CDSCO is the regulatory body for drugs and cosmetics in India. It is responsible for approving new drugs and ensuring the safety and quality of marketed drugs.
About Akum Pharma
Akum Pharma is a pharmaceutical company based in India. It manufactures and markets a wide range of generic drugs, including antidiabetic drugs.
Conclusion
The CDSCO panel’s request for more information on the FDC of Lobeglitazone and Sitagliptin is a sign that the agency is taking a cautious approach to the approval of new FDCs. This is a positive development, as it ensures that patients have access to safe and effective medications.
