Santhera receives Fast Track designation from FDA for Raxone/Catena in DMD

Mitochondrial and neuromuscular specialist Santhera (SIX: SANN) has received Fast Track designation from the US Food and Drug Administration for Raxone/Catena (idebenone) for Duchenne muscular dystrophy.

The Fast Track program facilitates the development and review of drugs that are intended to treat serious conditions and fill an unmet medical need in order to get them to the patient earlier. Santhera has announced Phase III results of the DELOS trial in Duchenne muscular dystrophy, showing that the trial met its primary endpoint and that Raxone/Catena delayed the loss of respiratory function.

Thomas Meier, chief executive of Santhera, said: "We are very pleased that the FDA has granted Fast Track designation for Raxone/Catena, which further underscores the unmet medical need for effective treatments for patients with DMD. On the basis of the positive data from our Phase III trial with Raxone/Catena in DMD, we have started to prepare a New Drug Application and plan to meet with the FDA in the coming weeks to discuss our NDA dossier in a pre-NDA meeting."