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Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval

 
• By Bridget Silverman

Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.

Breakthrough-designated products stand a good chance of getting US FDA approval. • Source: photo illustration - shutterstock images

Half of the clinical programs awarded breakthrough therapy designations have gone on to receive FDA approval, making the BTD one of the most successful of the FDA’s expedited review pathways, according to an analysis of the Pink Sheet’s US FDA Performance Tracker.

The FDA has awarded 437 BTDs since the program was introduced by the 2012 FDA Safety and Innovation Act (FDASIA). The Pink Sheet has identified 397 designations, which are tracked in detail on the Performance Tracker’s Breakthrough Therapy Designations chart

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