Orphazyme predicts EU rejection after meeting with CHMP

Biotech company Orphazyme is not holding out much hope for an EU approval of its candidate arimoclomol after its meeting with the expert committee CHMP on Wednesday.


An indicative vote taken on Wednesday by the CHMP, an expert panel that is part of the European Medicines Agency, did not result in a majority in favor of recommending Orphazyme’s candidate arimoclomol for approval in the region. The CHMP (Committee for Medicinal Products for Human Use) was considering arimoclomol for the indication Niemann Pick type C, a rare metabolic disease also known as NPC.

The company reported the results of this vote itself after being summoned to a meeting with the committee to answer questions about the drug.

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