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GLOSSARY

Breakthrough Therapy Designation

DEFINITION

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 a 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.

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