Breakdowns In The Breakthrough Lane: When Recipients Of FDA Expedited Designation Fall Short

Eiger BioPharmaceuticals, Inc.’s peginterferon lambda, Gilead Sciences, Inc.’s magrolimab, Takeda Pharmaceutical Co. Ltd.’s TAK-994 and Bavarian Nordic A/S’s RSV vaccine are the latest entrants to the small group of products that received breakthrough therapy designations but went on to struggle with clinical failure, changing strategic priorities, and regulatory missteps.

The BTD program is a success by most any measure. The Pink Sheet US FDA Performance Tracker has identified close to 500 designations granted since BTD was introduced in 2015. Nearly 60% have gone on to approval