Orphazyme to discuss NPC rejection with FDA in mid-October

Denmark-based biotech company Orphazyme has planned a meeting with the US Food and Drug Administration to discuss the rejection it received in June.

Photo: Nikolaj Skydsgaard/REUTERS / X07081

Progress appears to have been made in Orphazyme's ongoing battle to get its key candidate, arimoclomal, approved as a treatment for Niemann-Pick Type C (NPC) in the US.

Orphazyme's application for marketing authorization for the candidate was rejected by the US Food and Drug Administration (FDA) in June.

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