BRIEF—European regulator to consider vamorolone in DMD

The European Medicines Agency is to proceed with its review of a submission for a novel drug, vamorolone, for the treatment of Duchenne muscular dystrophy (DMD).

Vamorolone binds to the same receptor as corticosteroids, but modifies its downstream activity, making it a dissociative anti-inflammatory drug.

Developed by Swiss rare disease company Santhera Pharmaceuticals, the firm is also submitting for a Priority Review in the USA, together with partner ReveraGen.

A decision from the European regulator is expected by the third quarter of 2023, and Santhera hopes to launch in the USA before the end of that year.

Vamorolone has been granted Orphan Drug status in the USA and in Europe for DMD, and has received Fast Track and Rare Pediatric Disease designations by the US FDA.