AstraZeneca announced that Ultomiris has gained approval in the U.S., positioning it as the first and only long-acting C5 complement inhibitor suitable for treatment of adult patients diagnosed with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder. The FDA granted its approval based on favorable results presented by the CHAMPION-NMOSD Phase III trial.
Neuromyelitis optica spectrum disorder (NMOSD) is a rare but severe autoimmune disorder that impacts the central nervous system, particularly the spinal cord and optic nerves.
Apart from the U.S., Ultomiris is authorized for use amongst certain NMOSD adults in Japan and the European Union, and AstraZeneca is in the process of obtaining regulatory approval in other countries.
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