Santhera submits FDA meeting request to discuss Raxone NDA

Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN) has submitted briefing material and a meeting request to the US Food and Drug Administration (FDA) to discuss the filing of a New Drug Application (NDA) for Raxone (idebenone) for the treatment of Duchenne muscular dystrophy (DMD) patients not taking concomitant glucocorticoids, the company has announced.

The submission included a comprehensive data package containing data from Santhera’s Phase II (DELPHI) and Phase III (DELOS) studies, both of which demonstrated a clinically relevant and statistically-significant benefit of idebenone treatment in slowing the rate of respiratory function decline compared to placebo.