FDA approves Genentech’s drug for rare disease affecting optic nerves, spinal cord

The FDA has approved Enspryng (satralizumab-mwge) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adults with a certain antibody — patients who are anti-aquaporin-4 or AQP4 antibody-positive.

NMOSD is a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord. Enspryng, made by Genentech, is the third approved treatment for the disorder.

In patients with NMOSD, the immune system mistakenly attacks healthy cells and proteins, most often those in the optic nerves and spinal cord. This typically results in attacks of optic neuritis, which causes eye pain and vision loss. Approximately 50% of patients with NMOSD have permanent visual impairment and paralysis caused by NMOSD attacks. Estimates vary, but NMOSD is thought to affect approximately 4,000 to 8,000 Americans.

NMOSD may be associated with antibodies that bind to a protein called aquaporin-4 (AQP4). Binding of the anti-AQP4 antib…

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