The Central Drug Standard Control Organization (CDSCO) has suggested revising the phase III clinical trial protocol for Zydus Healthcare’s Empagliflozin plus Metoprolol Succinate fixed-dose combination (FDC). The CDSCO’s suggestion aims to enhance the design and methodology of the trial, ensuring that it can provide more robust and reliable data for the approval of this new drug combination.
The CDSCO’s panel, which is responsible for overseeing clinical trials in India, has requested revisions to the protocol based on various factors, including the study’s duration, patient population, and endpoints. Specifically, the panel wants to see a longer trial duration to assess the long-term effects of the FDC on patients with type 2 diabetes.
The FDC, a fixed-dose combination of Empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and Metoprolol Succinate, a beta-blocker, is being developed for the treatment of type 2 diabetes. The combination aims to improve glycemic control, reduce blood pressure, and lower the risk of cardiovascular disease.
Despite the CDSCO’s suggestions, the trial has already completed its phase II clinical trial, and Zydus Healthcare is now working to address the panel’s concerns and revise the protocol for phase III. The revised protocol will ensure that the study is more robust, well-designed, and can provide high-quality data to support the approval and registration of the FDC in India.
The revised protocol will likely include a longer study duration, increased patient numbers, and a more comprehensive set of endpoints to assess the efficacy and safety of the FDC. The trial will also need to demonstrate the superiority of the FDC over standard of care or other treatment options.
The revised protocol will be critical in ensuring that the FDC meets the necessary regulatory requirements, including those set by the Indian CDSCO. The approval of the FDC will depend on the successful completion of the revised phase III trial, which is expected to take around 2-3 years to complete.