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.

Data from the Cooperative International Neuromuscular Research Group’s (CINRG) Duchenne natural history study(DNHS), which were used to conduct the first prospectively planned external control group study comparing outcomes for patients taking part in DELOS with those taking part in CINRG DNHS, were also included.