Santhera prepares to request approval for idebenone in DMD

Published Date
28/03/2019
Author
Beatriz Bustillo Ramirez
Category
Research
Orange box stating: Breaking news research

Santhera Pharmaceuticals has provided an update on its plans to request approval for Puldysa in Duchenne muscular dystrophy. The active ingredient in this drug is idebenone, an antioxidant that has the potential to slow down respiratory decline in people with the condition. Back in 2017, Santhera requested authorisation for idebenone under the brand name Raxone, but the application was refused by the European Medicines Agency (EMA). Since then, the company has gathered additional data on the drug’s efficacy and changed the brand name in order to fulfil requests from regulators. Santhera is now planning to send a new application to EMA in the second quarter of 2019.

For more information, read Santhera’s press release.

If you have any questions about this news story or any other DMD research, please contact the MDUK Research Line on 020 7803 4813 or email research@musculardystrophyuk.org.

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