Sanofi : FDA Accepts Dupixent For Review In Children With Moderate-to-severe Asthma

赛诺菲:FDA接受Dupixent用于中重度哮喘儿童的审查

2021-03-05 12:51:55 RTTNews

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Regeneron Pharmaceuticals Inc. and Sanofi said that the U.S. Food and Drug Administration has accepted for review the supplemental Biologics License Application or sBLA for Dupixent or dupilumab as an add-on treatment for children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. The submission was supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial. The companies noted that the acceptance represents another milestone in the development of Dupixent in addressing diseases driven by type 2 inflammation. Dupixent is currently approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma aged 12 and older with elevated eosinophils or oral corticosteroid dependent asthma. The target action date for the FDA decision is October 21, 2021 and the European Union regulatory submission for children aged 6 to 11 years with asthma is planned for the first-quarter 2021. For comments and feedback contact: editorial@rttnews.com Business News
再生元制药公司和赛诺菲公司表示,美国食品和药物管理局已接受Dupixent或dupilumab的补充生物制剂许可申请或sBLA进行审查,作为6至11岁患有未控制的中重度哮喘儿童的附加治疗。 在一项随机3期试验中,Dupixent显著减少了严重的哮喘发作,是唯一一种改善6-11岁儿童肺功能的生物药物。 两家公司指出,这是Dupixent在解决由2型炎症引起的疾病方面的又一个里程碑。 Dupixent目前被批准为一种附加疗法,用于12岁及12岁以上嗜酸性粒细胞升高的未控制中重度哮喘或口服皮质类固醇依赖性哮喘患者。 FDA决定的目标行动日期为2021年10月21日,欧盟针对6-11岁哮喘儿童的监管文件计划于2021年第一季度提交。 如需评论和反馈,请联系:editorial@rttnews.com 商业新闻

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