Breakthrough Therapy Designation
If something receives a breakthrough therapy designation, the designation is designed to expedite the approval process. Typically, this designation is given if there is preliminary clinical evidence that therapy being developed has the potential to significantly improve existing treatments or create a new category of effective treatment altogether. There are numerous examples of substances being given a breakthrough therapy designation over the years, with one example being the esketamine nasal spray Spravato. This treatment was found to be particularly effective at treating depression, so it was given a breakthrough therapy designation to fast-track it through the approval process. After being given a breakthrough therapy designation, the treatment can still be given full approval by the FDA down the road.