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AstraZeneca PLC on Wednesday announced that eculizumab, whose brand name is Solaris, has been approved in China to treat patients with neuromyelitis optica spectrum disorder The Cambridge, Massachusetts-based pharmaceutical firm said that Solaris is now the first and only complement inhibitor approved for NMOSD by China’s National Medical Products Administration. AstraZeneca said the approval, for treatment of adults with NMOSD who are anti-aquaporin-4 antibody positive, was based on results from the Phase 3 clinical Prevent trial. NMOSD is a ‘rare and debilitating’ autoimmune disease which affects the spine, optic nerves and other parts of the central nervous system. Most patients will experience ‘unpredictable relapses’ which cause a new onset of ‘severe and recurrent’ neurologic symptoms or the worsening of existing ones. These can result in permanent disabilities. AstraZeneca said that during the Prevent study, Solaris met the primary endpoint of prolonging the time until a patient’s first adjudicated relapse, and of reducing the risk of relapse. Of the patients treated with Solaris, 98% were relapse-free at 48 weeks compared with 63% of patients taking a placebo. At 144 weeks, 96% of patients on Solaris remained relapse-free compared with 45% of the placebo group. Solaris was already available in China to treat adults with refractory generalised myasthenia gravis, and to treat adults and children with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome. ‘Patients with NMOSD and their families should not have to live in fear of the next relapse and potential complications,’ said Marc Dunoyer, chief executive officer at Alexion or AstraZeneca Rare Disease. The group was created following AstraZeneca’s acquisition of Alexion Pharmaceuticals Inc in 2021. Dunoyer continued: ‘We are proud to bring our first-in-class C5 inhibitor Soliris to the NMOSD community in China, reflecting our commitment to transforming the lives of people living with rare neurological diseases and expanding access to our medicines around the world.’ AstraZeneca shares were down 1.3% at 11,122.00 pence in London on Wednesday morning. Copyright 2023 Alliance News Ltd. All Rights Reserved.
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