Orphazyme Wants More Time To Deal With Late-Stage Issues For Arimoclomol In EU
Other Sponsors Also Ask For A Longer Pause To CHMP’s Review Clock
Following Orphazyme’s disappointment in the US regarding its investigational drug for an ultrarare disease, the company has said it will need more time to address outstanding issues raised by EU reviewers about the same medicine.
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Danish biotech Orphazyme has withdrawn the EU marketing application for its Niemann-Pick disease type C therapy arimoclomol and all hopes for the drug’s survival now rest on a meeting with the US Food and Drug Administration.
All hopes for survival rest on a meeting with the US FDA about arimoclomol now that the Danish biotech has withdrawn its submission for the Niemann-Pick disease type C therapy with the European Medicines Agency.
The EMA's medicines evaluation committee has told Orphazyme it is unlikely to recommend approval of the rare disease drug arimoclomol when it meets at the end of March, prompting the Danish firm to assess its strategic options.