What was the BreatheDMD Program?

BreatheDMD was an expanded access program that had been authorized by the Food and Drug Administration (FDA). Expanded access is the use of an investigational medical product (one that has not been approved by the FDA) outside of a clinical trial for a serious disease or condition for which there is no comparable or satisfactory therapy available.

As of October 2020; Santhera Pharmaceuticals has made the decision to discontinue the development of idebenone in Duchenne muscular dystrophy. BreatheDMD Access Program is discontinued at this time.