Dupixent满足了过敏真菌犀牛皮炎的所有试验目标,林业发展局预计将在2026年2月底作出决定。
Dupixent met all trial goals for allergic fungal rhinosinusitis, with FDA decision expected by late February 2026.
Sanofi和Regeneron宣布,Dupixent在晚期对过敏真菌犀牛皮炎进行试验时,满足了所有初级和二级终点,这一慢性病导致鼻炎和拥塞。
Sanofi and Regeneron announced that Dupixent met all primary and secondary endpoints in a late-stage trial for allergic fungal rhinosinusitis, a chronic condition causing nasal polyps and congestion.
这种药物大大改善了6岁及以上病人的症状并减少了聚虫。
The drug significantly improved symptoms and reduced polyps in patients aged 6 and older.
林业发展局已接受该药物的补充生物许可证申请,要求优先审查,预计将在2026年2月底作出决定。
The FDA has accepted the drug’s supplemental biologics license application for priority review, with a decision expected by late February 2026.
如果获得批准,Dupixent公司将获得林业发展局第九份说明,其安全情况与以往用途一致。
If approved, Dupixent would gain its ninth FDA indication, with a safety profile consistent with prior uses.