Astrazeneca announced that it has received approval in Japan for Ultomiris® (ravulizumab). Ultomiris is the first and only long-acting C5 complement inhibitor approved for preventing relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica. The approval was based on positive results from the CHAMPION-NMOSD Phase III trial, which demonstrated the efficacy of Ultomiris® in preventing relapses.
Ultomiris was also recently approved in the EU for NMOSD treatment, and regulatory reviews are ongoing in other countries including the US.
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