Orphazyme plans to resubmit FDA application in H2

After drug candidate arimoclomol, a treatment of metabolic disease Niemann-Pick C, was rejected by the US Food and Drug Administration last year, Orphazyme now aims to file another application at the agency in the second half of the year.

Photo: Orphazyme/PR

On Friday morning, windswept biotech firm Orphazyme has announced its intention to resubmit an application to the US Food and Drug Administration (FDA) for arimoclomol, a potential treatment of the metabolic disease known as Niemann-Pick type C (NPC).

Orphazyme’s lead candidate was rejected by the FDA in a so-called ”complete response letter” in June of last year.

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