Santhera tanks as FDA rejects request for accelerated Raxone review

Shares in Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN) were sent tumbling on Thursday as markets learnt that the US Food and Drug Administration had not accepted its request for accelerated review of Duchenne muscular dystrophy (DMD) treatment Raxone (idebenone).

Santhera had sought an expedited assessment via the subpart H approval pathway of Raxone in DMD patients not taking concomitant glucocorticoids.

The company had proposed that the planned SIDEROS trial would provide confirmatory evidence of efficacy in these patients while expanding the label to include the treatment of glucocorticoid-using patients.