This page shows the latest idebenone news and features for those working in and with pharma, biotech and healthcare.
European regulatory advisers have refused to shift their negative position on Santhera’s Duchenne muscular dystrophy (DMD) drug Raxone (idebenone).
The Swiss biopharma company has failed to convince the FDA to accept an accelerated marketing application for Raxone (idebenone) via the truncated subpart H approval pathway, used to hasten the approval
There has been some good news for European DMD patients this week however after Santhera announced it had filed for approval of Raxone (idebenone) for the treatment of DMD.
And finally the CHMP has recommended Santhera's Raxone (idebenone) for the treatment of visual impairment in patients with Leber's hereditary optic neuropathy. .
Other companies bringing DMD therapies through the pipeline include Santhera, whose Raxone/Catena (idebenone) candidate has completed phase III testing.
for approval of Catena/Raxone (idebenone) -used to support lung function in DMD patients - in the coming months.
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