CHMP negative opinion leaves cash-strapped Santhera fighting the orphan data battle
This article was originally published in Scrip
Executive Summary
The future looks uncertain for Santhera Pharmaceuticals as the European Medicines Agency's Committee for Medicinal Products for Human Use has narrowly decided to recommend against approval of the Swiss firm's idebenone for the treatment of the rare genetic disease Leber's hereditary optic neuropathy (LHON).