Source: European Medicines Agency
Area: News
The Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion, recommending the refusal of the marketing authorisation for the orphan medicine idebenone (Raxone®), intended for the treatment of patients with Leber's hereditary optic neuropathy (LHON), an inherited disease characterised by progressive loss of sight.
The company presented the results from one main randomised, placebo-controlled study involving 85 patients with LHON whose symptoms started in the previous five years. The main measure of effectiveness was the change in vision after (Read more...)
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