AstraZeneca Announces FDA Approval For Ultomiris - Quick Facts

(RTTNews) - AstraZeneca (AZN.L, AZN) said Ultomiris has been approved in the United States as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder. The FDA approval was based on positive results from the CHAMPION-NMOSD Phase III trial.

NMOSD is a rare and debilitating autoimmune disease that affects the central nervous system, including the spine and optic nerves.

Ultomiris is also approved for certain adults with NMOSD in Japan and the European Union. The company said regulatory reviews are ongoing in additional countries.

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