Updated: Dec 6, 2022
"Orphazyme announces withdrawal of European Marketing Authorisation Application for arimoclomol for the treatment of Niemann-Pick disease type C"
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Decision to withdraw the European Marketing Authorisation Application comes ahead of scheduled final vote on the application later this month
Orphazyme intends to request Type C Meeting with the U.S. Food and Drug Administration to discuss potential pathway for resubmission of the New Drug Application for arimoclomol for Niemann-Pick disease type C
"Considering the Company’s financial position, Orphazyme has now entered in-court restructuring. This is a process designed to assess the basis to secure the activities of the company going forward including a basis for injecting further capital and/or a potential sale of all or some assets in the company. We firmly believe that arimoclomol has the potential to help NPC patients and we are motivated to explore options for a regulatory path forward in both Europe and the US. We remain focused on preparing for the Type C meeting with the FDA. Our core team of employees is committed to facilitating continued access to arimoclomol to NPC patients during this time" - Tara Greene (Sr. Director, US Medical Operations and US Patient Advocacy, Orphazyme US, Inc.)