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.