Posted by Michael Wonder on 18 Dec 2019
Orphazyme’s arimoclomol receives US fast track designation in sporadic inclusion body myositis
18 December 2019 - Orphazyme today received fast track designation from the US FDA for the development of arimoclomol for the treatment of sporadic inclusion body myositis.
Results from the phase 2/3 trial with arimoclomol for sporadic inclusion body myositis are expected in the first half of 2021. Following a strong recommendation from the EMA, the trial protocol is amended to omit an interim analysis (originally scheduled for H1 2020).
