(News Bulletin 247) – AstraZeneca announces that Ultomiris (ravulizumab) has been approved in Japan for the prevention of relapses in patients with neuromyelitis optica spectrum disorder (NMOSD) positive for anti-aquaporin-4 antibodies, a disease auto -rare and debilitating immune disease that affects the central nervous system (CNS), including the spine and optic nerves.
Approval by the Japanese Ministry of Health, Labor and Welfare (MHLW) was based on positive results from a phase III trial whose results were recently published in the Annals of Neurology and selected as an abstract of distinction at the 2023 American Academy of Neurology Annual Meeting.
“Because a single NMOSD relapse can lead to long-term disability and life-altering consequences, preventing relapses is the main goal of treatment in this area,” explained Ichiro Nakashima, a professor in the Division of Neurology at the Tohoku Medical and Pharmaceutical University (Japan).
With no relapses seen in the trial, approval of Ultomiris is a significant step forward for patients with dosing every eight weeks and the chance to live relapse-free.
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