The US FDA’s Breakthrough Therapy demands sufficient preliminary clinical evidence to prove a compelling proof-of-concept; for instance the drug must show substantial improvement on a significant clinical endpoint when compared with current therapies. If these criteria are met, the US FDA is able to expedite the development and review of drug candidates that are able to treat serious of life threatening diseases.
In this book, we track down 5 breakthrough therapeutics:
- Who developed them
- What we can hope for over the coming years
- Their relevance to Asia