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国家药监局批准伟立瑞用于治疗视神经脊髓炎谱系疾病成人患者
Guang Zhou Ri Bao· 2025-08-01 10:25
Core Points - The National Medical Products Administration has approved Weili Rui® for the treatment of adult neuromyelitis optica spectrum disorder (NMOSD) patients who are positive for aquaporin-4 (AQP4) antibodies, based on positive results from the CHAMPION-NMOSD Phase III clinical trial [1] - The trial demonstrated that the treatment group receiving Riluzumab did not experience any relapses during a median treatment duration of 73 weeks, and the results were consistent over a longer follow-up period of 170.3 weeks [1] - NMOSD is a rare, highly disabling autoimmune disease characterized by unpredictable relapses that can lead to severe neurological damage and permanent disability [1] Group 1 - The CHAMPION-NMOSD Phase III clinical trial used the placebo group from the PREVENT pivotal trial as an external control [1] - Riluzumab achieved the primary endpoint of time to first relapse as determined by an independent adjudication committee [1] - Most patients in the Riluzumab treatment group maintained stable or improved disability assessment scores during the follow-up period [1] Group 2 - Professor Quan Chao from Huashan Hospital emphasized the importance of preventing relapses during remission and quickly controlling symptoms during acute phases to minimize disability accumulation [2] - Riluzumab is a long-acting complement inhibitor that can precisely target complement pathways, providing sustained benefits for patients [2] - AstraZeneca's global senior vice president, Dr. He Jing, noted that this is the second indication approved for Riluzumab in China within six months, highlighting the drug's innovative value [2]