MedWatch

Orphazyme board member on expected EMA rejection: "The next few days will be hell"

Arimoclomol has shown statistical significance as a treatment for Niemann-Pick type C, says Orphazyme Deputy Chairman of the Board Bo Jesper Hansen, who does not understand how the EMA can reject the candidate or why they have tightened up the rules for statistical significance.

Bo Jesper Hansen, deputy chair of the board, Orphazyme | Photo: Kåre Viemose

As well as holding the deputy chair position on the board of Orphazyme, Bo Jesper Hansen is something of a celebrity within the treatment of rare diseases, having also co-founded Swedish Orphan Biovitrium, Sobi.

Hansen sold his shares in Swedish Orphan Biovitrium, Sobi in 2016 and stepped down from the board, and has been on the board of Danish biotech company Orphazyme since 2010, observing the development of arimoclomol, which has been submitted to both the FDA and EMA for approval as a treatment for rare metabolic disease Niemann-Pick type C (NPC).

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