FDA 批准阿斯利康的 Ultomiris 用于治疗具有 AQP4 抗体的成人 NMOSD 患者。 FDA approves AstraZeneca's Ultomiris for treating adult NMOSD patients with AQP4 antibodies.
阿斯利康的 Ultomiris (ravulizumab-cwvz) 已获得 FDA 批准，用于治疗抗水通道蛋白 4 (AQP4) 抗体阳性的视神经脊髓炎谱系障碍 (NMOSD) 成年患者。 AstraZeneca's Ultomiris (ravulizumab-cwvz) has been approved by the FDA for treating adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD). 该批准基于 CHAMPION-NMOSD III 期试验，该试验显示与安慰剂相比，复发风险显着降低。 The approval was based on the CHAMPION-NMOSD Phase III trial, which showed a significant reduction in relapse risk compared to a placebo. Ultomiris 是第一个也是唯一一个被批准用于该适应症的长效 C5 补体抑制剂，并且已经在日本和欧盟被批准用于某些患有 NMOSD 的成人。 Ultomiris is the first and only long-acting C5 complement inhibitor approved for this indication, and it is already approved for certain adults with NMOSD in Japan and the European Union.