EMA validates Santhera's Marketing Authorization Application for Raxone

5 June 2014

The European Medicines Agency has validated a Marketing Authorization Application (MAA) for Leber’s hereditary optic neuropathy (LHON) from Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN).

The company refiled its MAA for Raxone (idebenone) last month after an earlier application was withdrawn in March 2013 in order to include additional clinical efficacy data. Santhera expects a decision from the EMA in the first half of 2015.

The validation was based upon the pivotal RHODOS trial, which showed a significantly higher proportion of Raxone-treated patients presented with clinically relevant recovery in visual acuity (VA) compared to placebo, and on two additional datasets from the expanded access program (EAP) and a case record survey (CRS) which provide supportive efficacy and natural history data.

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