AstraZeneca: Soliris approved in China for NMOSD
(CercleFinance.com) - AstraZeneca announces that Soliris (écoulizumab) has been approved in China for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin-4 (AQP4) antibodies (Ab+).
NMOSD is a rare, debilitating autoimmune disease that affects the central nervous system (CNS), including the spine and optic nerves.
Soliris thus becomes the first and only complement inhibitor approved for the treatment of NMOSD in China.
The approval by the National Medical Products Administration (NMPA) in China was based on the results of a Phase III trial showing that, at 48 weeks, 98% of patients treated with Soliris were relapse-free, compared with 63% of patients receiving placebo.
In addition, 96% of Soliris-treated patients remained relapse-free at 144 weeks, compared with 45% of placebo-treated patients.
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NMOSD is a rare, debilitating autoimmune disease that affects the central nervous system (CNS), including the spine and optic nerves.
Soliris thus becomes the first and only complement inhibitor approved for the treatment of NMOSD in China.
The approval by the National Medical Products Administration (NMPA) in China was based on the results of a Phase III trial showing that, at 48 weeks, 98% of patients treated with Soliris were relapse-free, compared with 63% of patients receiving placebo.
In addition, 96% of Soliris-treated patients remained relapse-free at 144 weeks, compared with 45% of placebo-treated patients.
Copyright (c) 2023 CercleFinance.com. All rights reserved.