1 July 2024 - The FDA’s breakthrough therapy designation program was created to increase patient access to safe and effective therapies by supporting the efficient clinical development of qualifying, clinically meaningful therapies. 

Using a new data set of key development milestones for drugs approved between 2006 and 2020, including both breakthrough therapy designation drugs and a set of comparator drugs identified by FDA experts, we estimated the breakthrough therapy designation program’s impact on time spent in late-stage clinical development, measured as the elapsed time between a drug’s end of Phase 2 meeting with regulators and its approval for marketing.

Read Health Affairs article