Santhera regrets to inform the Duchenne community, that based on the results of the SIDEROS trial interim analysis and recommendation from the trial’s Data and Safety Monitoring Board (DSMB), that we have made the decision to discontinue the development of idebenone in Duchenne muscular dystrophy. The BreatheDMD Access Program is discontinued at this time. Please click here to access the press release and letter to the Duchenne community to learn more about what led to this decision. All participants in the expanded access program should contact their study site and discontinue the investigational therapy immediately. Additional questions about the announcement can be directed to Jodi Wolff, Head of Patient Advocacy – U.S. at Jodi.firstname.lastname@example.org. Participants in the program should contact their study site with additional questions.
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.
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