On June 23, 2020, Santhera Pharmaceuticals announced the UK’s renewal of its early access program for idebenone, a medication used to treat Duchenne patients who are experiencing respiratory function decline, and not taking glucocorticoids.
The UK’s Medicines and Health products Regulatory Agency (MHRA) has recognized the positive risk/benefits of idebenone in Duchenne patients. As a result, they have renewed their early access program for one more year. Santhera continues to wait for regulatory approval in the UK, which is expected to come sometime in the last quarter of this year.
Defeat Duchenne Canada has reached out to Santhera to discuss plans for Canada. Santhera is currently recruiting for their phase three clinical trial (click here for full clinical trial information); however, there are no sites listed for Canada.
If this is a medication you would like to learn more about or find out if you are eligible to access through Canada’s Special Access Program, please speak to your physician.
If you have any questions about this or any other news from Defeat Duchenne Canada, please contact:
Director of Research and Advocacy
Defeat Duchenne Canada
Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company committed to developing and commercializing innovative medicines to meet the needs of patients living with rare and other diseases with high unmet medical needs.