Ultomiris approved in Japan for the prevention of relapses in patients with neuromyelitis optica spectrum disorder
Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica
The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from the CHAMPION-NMOSD Phase III trial, which were recently published in the Annals of Neurology (previously cited) and selected as an abstract of distinction at the 2023 American Academy of Neurology Annual Meeting. In the trial, Ultomiris was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial.
Ultomiris met the primary endpoint of time to first on-trial relapse as confirmed by an independent adjudication committee. Zero relapses were observed among Ultomiris patients with a median treatment duration of 73 weeks (relapse risk reduction: 98.6%, hazard ratio (95% CI): 0.014 (0.000, 0.103), p<0.0001) and continuing through a median duration of 90 weeks.
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