AstraZeneca announced that its Ultomiris® (ravulizumab) has a new indication approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) 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 was based on AZ’s phase III clinical trial where Ultomiris® was compared to an external placebo arm from the Alexion Soliris® (Eculizumab) PREVENT clinical trial.
Two weeks ago the European Commission approved Ultomiris® for the same condition above.