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FDA Acceptance of The Data from Traditional Chinese Medicine for Heart Health
(Thursday, November 2, 2023) A recent publication of a placebo-controlled clinical trial in China with a Traditional Chinese Medicine (TCM) product showed signification benefits in the management of Acute ST-segment elevation myocardial infarction (STEMI). However, what would be the likelihood of FDA acceptance of clinical data from such a study to support its approval as a conventional drug? 0 The trial was designed to ICH standards and followed principles of Good Clinical Practices (GCP), data integrity, and adequate analysis. It was also conducted to Western medicine standards. From a scientific perspective, the results of the study were acceptable and seemed very promising. The study met the primary endpoint. However, the challenge for the investigational product is in terms of its origin. The compound, referred to as Tongxinluo, consists of a mixture of powders and extracts derived from plants, centipedes, cicada, and other sources. Among the various components of this compound, there are no known active ingredients that would be expected on a mechanistic basis to favorably affect cardiovascular disease. Products like this are designated as botanical drug products (BDP). Although the FDA has released a few guidance documents for the development and market approval of BDPs, there have been only two drugs approved in the last 15 years as BDPs. The main challenge with BDPs is that these products cannot be studied like conventional drug products. These products contain mixtures of unknown ingredients not known to Western science and almost impossible to characterize. Although, in principle, the FDA promises to treat BDPs differently, it still expects characterization like that expected from conventional drug products. The clinical trial data from Tongxinluo, while quite promising from a scientific perspective, still must go through the FDA review process, which is a long way to go. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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