日本批准6-11患严重哮喘、改善肺功能和减少发烧的6-11岁儿童的Dupixant。
Japan approves Dupixent for kids 6–11 with severe asthma, improving lung function and reducing flare-ups.
日本已经批准为6至11岁儿童提供Dupixent (depilumab) 治疗与第2类炎症有关的中度至严重程度无节制支气管哮喘,使其成为在第三阶段试验中显示该年龄组肺功能改善的第一个生物实验。
Japan has approved Dupixent (dupilumab) for children aged 6 to 11 with uncontrolled moderate-to-severe bronchial asthma linked to type 2 inflammation, making it the first biologic to show improved lung function in this age group in a Phase 3 trial.
根据VOYAGE试验的核准结果显示,严重哮喘病恶化和肺功能改善减少54%至65%,在列入标准疗法时比安慰剂减少4.68%至5.32%。
The approval, based on the VOYAGE trial, shows a 54% to 65% reduction in severe asthma exacerbations and improved lung function by 4.68% to 5.32% versus placebo when added to standard therapy.
毒品的目标是IL-4和IL-13,是第2类发炎的关键驱动因素,针对的对象是没有受到现有治疗适当控制的儿童。
The drug targets IL-4 and IL-13, key drivers of type 2 inflammation, and is intended for children not adequately controlled by existing treatments.