WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration has approved Uplizna injection for the treatment of a rare disease affecting the optic nerves.
Uplizna has been approved to treat neuromyelitis optica spectrum disorder in adult patients with a particular antibody. The disease 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.'
In patients with NMOSD, the body's immune system mistakenly attacks healthy cells and proteins in the body, most often those in the optic nerves and spinal cord. Individuals with NMOSD typically have attacks of optic neuritis, which causes eye pain and vision loss. Individuals also can have attacks resulting in transverse myelitis, which often causes numbness, weakness, or paralysis of the arms and legs, along with loss of bladder and bowel control.
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