Posted by Michael Wonder on 28 May 2019
Santhera submits marketing authorisation application to the European Medicines Agency for Puldysa (idebenone) in Duchenne muscular dystrophy
27 May 2019 - Santhera Pharmaceuticals announces that it has submitted a marketing authorisation application for Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy to the EMA.
Santhera is seeking conditional marketing authorisation (CMA).
The indication for Puldysa sought under CMA is the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy who are not using glucocorticoids. The MAA is supported by data from Santhera's Phase II (DELPHI) study, the long-term DELPHI-Extension study, the pivotal Phase III (DELOS) study and the recently completed SYROS study, a collection of long-term data from patients who completed the DELOS study and continued to be treated with idebenone for up to six years.
