CHMP recommends marketing authorization for Santhera's Raxone

Swiss drugmaker Santhera (SIX: SANN) has received a recommendation for marketing authorization for its Raxone (idebenone) from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The marketing authorization has been recommended for Raxone in the treatment of visual impairment in adolescent and adult patients with Leber’s hereditary optic neuropathy (LHON). This is a heritable mitochondrial disease that leads to rapid, profound and usually permanent blindness in patients who are otherwise healthy.

Thomas Meier, chief executive of Santhera, said: "We are very excited about the CHMP's positive opinion, which recognizes the urgent medical need for a treatment for this devastating disease. We can now execute on our plans to ensure Raxone is made available to patients in the EU as soon as the European Commission marketing authorization is received."