FDA approves new therapy for rare disease affecting optic nerve, spinal cord
The U.S. Food and Drug Administration today approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients with a particular 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. Uplizna is only the second approved treatment for the disorder.
“Until recently, patients with NMOSD had no FDA-approved treatment options,” said Billy Dunn, M.D., Director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “Uplizna now represents the second approved therapy for these patients within the past year. We continue to remain highly committed to the development of additional safe and effective drugs for this rare and devastating disease.”
Read the full press release here.