一地疫情急剧恶化，已出现18例死亡
当地时间3月11日，美国食品药品监督管理局（FDA）宣布批准单克隆抗体药物eculizumab用于治疗6岁及以上儿童全身型重症肌无力（gMG）。这是该群体首个靶向疗法。此前， Eculizumab已于2007年获准用于成人gMG及其他免疫性疾病。
欧洲麻疹疫情骤升，重症肌无力儿童新疗法带来希望
与此同时，欧洲麻疹疫情的急剧恶化引发了广泛关注。根据欧洲疾病预防控制中心（ECDC）公布的数据，自2024年初以来，麻疹病例在欧盟及邻国飙升至32,000多例，其中罗马尼亚成为重灾区，病例累积达到27,568例，疫情已造成至少19人死亡。紧随其后的是意大利和德国，所有国家均未能幸免。ECDC警告，麻疹疫情的传播高峰通常出现在上半年，预计未来几个月病例数可能继续增加。值得注意的是，绝大多数感染者未接 ...
The American Journal of Managed Care8 天
FDA Approves Expanded Indication of Eculizumab for Pediatric Generalized Myasthenia Gravis
The FDA first approved eculizumab for use in adult patients with generalized myasthenia gravis in 2017, before expanding the ...
Nature4 年
Methods of Diagnosing and Treating CHAPLE, A Newly Identified Orphan Disease: Collaborative ...
Recent off-label use of a complement inhibiting drug, eculizumab (CD55 inhibitor) was shown to provide a dramatic benefit in patients with CHAPLE disease with an immediate correction of ...
Yahoo Finance13 天
FDA Approves Expanded Use of Eculizumab (Soliris) for Pediatric Myasthenia Gravis, Bringing ...
approval of the expanded indication of Alexion/AstraZeneca’s eculizumab (Soliris) for pediatric patients aged six years and older with generalized myasthenia gravis (gMG) who are anti ...
The Bakersfield Californian13 天
FDA Approves Expanded Use of Eculizumab (Soliris) for Pediatric Myasthenia Gravis, Bringing ...
The Muscular Dystrophy Association (MDA) welcomes the U.S. Food and Drug Administration (FDA) approval of the expanded indication of Alexion/AstraZeneca’s eculizumab ( ...