Orphazyme A/S's annus horribilis is getting more horrible by the week and the latest setback has seen the beleaguered Danish biotech pull the file in Europe for arimoclomol, its investigational treatment for the ultra-rare disorder Niemann-Pick disease type C (NPC).
The company announced on 22 March that it had withdrawn a marketing authorization application to the European Medicines Agency for arimoclomol, a move which comes as no surprise, given that the company was informed last month by the agency's Committee for Medicinal Products for Human Use (CHMP) of a "negative trend vote" towards the submission
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