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AstraZeneca Says Ultomiris Gets US FDA Approval to Treat Neuromyelitis Optica Spectrum Disorder
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AstraZeneca Says Ultomiris Gets US FDA Approval to Treat Neuromyelitis Optica Spectrum Disorder
Mar 25, 2024 6:30 AM

09:00 AM EDT, 03/25/2024 (MT Newswires) -- AstraZeneca ( AZN ) said Monday the US Food and Drug Administration has approved the Ultomiris C5 complement inhibitor to treat adult patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder.

Neuromyelitis optica spectrum disorder, or NMOSD, is a rare autoimmune disease that affects the central nervous system, including the spine and optic nerves.

The approval was based on the company's Champion-NMOSD phase 3 trial which met the primary endpoint, including zero relapses observed, the company said.

Japan and the European Union have already approved Ultomiris for select patients, the company said.

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