Santhera closer to market in DMD

Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN) has had its marketing authorization application (MAA) accepted for Puldysa (idebenone) to treat respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD) who are not using glucocorticoids.

The European Medicines Agency’s (EMA) acceptance of the MAA confirms that the submission, which was filed as a 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.

Idebenone is already approved in Europe for the treatment of the rare ophthalmology condition Leber's hereditary optic neuropathy, under the name Raxone. In DMD, it has been granted orphan drug designation and been made available under the UK’s Early Access to Medicines Scheme.