Botanicals are important sources of new drug discovery and development. As of December 2017, FDA received over 700 botanical investigational new drug applications (IND) and pre-IND meeting requests (PIND), with increased submission rates in the last several years. To date, two botanical new drug applications have been approved in the U.S., Veregen® in 2006 and Fulyzaq® in 2012.
In this presentation, we discuss our experience with these INDs containing a wide variety of botanical raw materials (single vs. multiple herbs), having various previous human experience, and originating from broad geographic regions. The data show that the indications for these proposed products have great diversity from cancer prevention/treatment, to mitigating common warts, to pain relief. One third of the indications were for oncology products. Given the inherent chemical and biological complexity of these products, ensuring therapeutic and quality consistency is often a challenge.
With accumulated experience and knowledge on botanical drug products, FDA revised the Botanical Drug Development-Guidance for Industry in December of 2016. The guidance was expanded to address the challenging issues for later phase trial and provided further recommendations to better facilitate botanical drug development by taking a holistic “Totality-of-Evidence” approach. This talk will highlight the implementing guidelines to our regulatory review practice.