FDA “Breakthrough Therapy” Designations

Breakthrough status was introduced in FDASIA to facilitate development and review of drugs to treat serious/life-threatening diseases where there is early evidence of a substantial improvement over existing therapies.

Breakthrough status was introduced in the 2012 FDA Safety and Innovation Act to expedite development and review of a potential new medicine intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. See below for a list of publicly announced breakthrough designations.

* At least six applications have been withdrawn

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