Santhera Confident Of Raxone DMD Success Despite Setbacks

The Swiss company believes it has collected sufficient new data on Raxone for Duchenne muscular dystrophy to convince regulators and hopes to file for that indication on both sides of the Atlantic by the end of the first quarter of 2019.

Fingers crossed
Santhera hopes for better luck with regulators • Source: Shutterstock

Santhera Pharmaceuticals AG is still convinced that there is a future for Raxone (idebenone) as a treatment for Duchenne muscular dystrophy (DMD) despite repeated knockbacks from European regulators, as sales of the drug in its already-approved indication of Leber’s hereditary optic neuropathy (LHON) continue to climb.

The Swiss drugmaker has had a tough time to date in its talks with the European Medicines Agency with the latter's evaluation committee, the CHMP, initially rejecting Santhera’s request for the DMD indication in September 2017

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