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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. FDA has not yet released details on the program, but at least 14 requests have been granted.

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. FDA has not yet released details on the program. See below for a list of publicly announced breakthrough designations.

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