Breakthrough therapy

Breakthrough Therapy is a new designation provided by the Food and Drug Administration Safety and Innovation Act (FDASIA).^[1]

According to Food and Drug Administration :

• It as a drug which is intended alone or in combination with one or more other drugs to treat a serious or life threatening disease or condition
• The preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.

See also

• List of drugs granted breakthrough therapy designation

References

•  This article incorporates public domain material from the United States Food and Drug Administration document "Fact Sheet: Breakthrough Therapies".