Santhera files for European approval of Puldysa in DMD

Swiss specialty pharma Santhera (SIX: SANN) on Monday submitted a marketing authorization application (MAA) to the European Medicines Agency, seeking conditional approval for its Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD).

The indication for Puldysa sought under the Conditional Marketing Application (CMA) is the treatment of respiratory dysfunction in patients with DMD who are not using glucocorticoids. Conditional approval gives companies the right to market a drug in Europe whilst they collect the data to support an application for a full licence in the future. 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.

The market for DMD drugs is expected to reach $4.11 billion by 2023, according to a recent report by Grand View Research.The therapy sector was valued at around $1.02 billion in 2018 by other analysts.