AstraZeneca’s Ultomiris (ravulizumab) Receives the MHLW’s Approval for the Prevention of Relapses in Patients with NMOSD
- The MHLW has approved Ultomiris (C5 complement inhibitor) for the prevention of relapses in patients with AQP4 Ab+ neuromyelitis optica spectrum disorder (NMOSD) incl. neuromyelitis optica
- The approval was based on the P-III trial (CHAMPION-NMOSD) evaluating Ultomiris in 58 patients across North America, the EU, Asia-Pacific & Japan. The trial met its 1EPs of time to first on-trial relapse as confirmed by an independent adjudication committee, zero relapses were seen with a median treatment duration of 73wks., 98.6% relapse risk reduction & continuing through a median duration of 90wks.
- The safety & tolerability were consistent with prior studies & real-world use with no new safety signals. The results were published in the Annals of Neurology
Ref: AstraZeneca | Image: AstraZeneca
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