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.

Genetic mutation, conceptual illustration
Niemann-Pick disease Type C Is Caused By Mutations Leading To Defective NPC Protein • Source: Alamy

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