Kathleen Hawker, MD, Group Medical Director at Genentech, discusses the recent FDA approval of satralizumab, the first subcutaneous treatment for adults with AQP4 antibody positive neuromyelitis optica spectrum disease (NMOSD).
NMOSD is a rare autoimmune disorder targeting the central nervous system and causing damage to the optic nerve and spinal cord. This damage causes blindness, muscle weakness, and paralysis.
The FDA approval of satralizumab is based on the results from two randomized, double-blind, placebo-controlled trials (the SAkuraStar and SAkuraSky studies) in which satralizumab demonstrated strong efficacy and a favourable safety profile in adults with AQP4 antibody positive NMOSD. Satralizumab was demonstrated to reduce the risk of NMOSD symptom relapse compared to both placebo (SAkuraStar study) and when used concurrently with baseline immunosuppressant therapy (SAkuraSky study).
Satralizumab works by inhibiting interleukin-6 receptor activity which is believed to play a significant role in the inflammation response underlying NMOSD. The treatment uses antibody recycling technology, which allows for longer antibody circulation and gives patients the option of at-home dosing every four weeks.
For more information about satralizumab and the recent FDA approval, visit https://www.gene.com/media/press-releases/14873/2020-08-14/fda-approves-genentechs-enspryng-for-neu
For more information about NMOSD and other rare neurological conditions, visit checkrare.com/diseases/neurology.