Posted by Michael Wonder on 15 Feb 2018
Statement from FDA Commissioner on advancing the development of novel treatments for neurological conditions; part of broader effort on modernizing FDA’s new drug review programs
15 February 2018 - New medical breakthroughs are altering how diseases are treated in ways that seemed unimaginable just a decade ago. Perhaps one of the most significant developments is the advent of new gene therapies and drugs that boost the immune system’s ability to target tumour cells.
But we recognise that progress across different therapeutic areas has been uneven, including for complex neurological diseases. In part, this is because the underlying causes of severe neurological diseases may not be as well understood compared to ailments like cancer. The brain, in many respects, is the last organ system where many aspects of our understanding of the underlying biology of disease remain uncertain.
Symptoms and progression of neurological diseases can also vary significantly across patients, and even within patients, and across organ systems. Some diseases, like Alzheimer’s, may progress invisibly for years. Once clinical symptoms become apparent, significant function may already be lost. These issues can make drug development more challenging for companies, and are deeply frustrating for patients and caregivers living with these serious and life-threatening conditions.
