EMA validates MAA for Puldysa for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy

Santhera Pharmaceuticals announces that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for Puldysa (idebenone) in the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) who are not using glucocorticoids. Validation confirms that the submission, which was filed as conditional marketing authorization (CMA), is complete and that the review process by the EMA's Committee for Medicinal Products for Human Use (CHMP) has begun. Santhera expects an opinion by the CHMP around mid 2020.