Orphacol market authorisation not a done deal

摘要

After having fought the European Commission all the way to the EU General Court, it seems that the French laboratory CTRS will just have to keep on waiting for a marketing authorisation for the drug Orphacol. Orphacol is an orphan medicinal product designed to treat rare and sometimes fatal liver disorders (an estimated 90 cases in Europe). In order to be able to market it, in October 2009, CTRS applied for a marketing authorisation. The European Medicines Agency (EMA) gave a positive opinion twice.