Roche applications for satralizumab in NMOSD accepted in U.S. and Europe

The FDA and European Medicines Agency have accepted for review marketing applications from Roche (OTCQX:RHHBY) seeking approval of satralizumab for the treatment of adolescent and adult patients with neuromyelitis optica spectrum disorder (NMOSD), an inflammatory disease affecting the central nervous system, predominantly the optic nerves and spinal cord.

The EMA accepted the filing under Accelerated Assessment status. The IL-6 inhibitor has Breakthrough Therapy status in the U.S.

Decisions from both regulators are expected in 2020.

https://seekingalpha.com/news/3511359-roche-applications-satralizumab-nmosd-accepted-u-s-europe