美国食品和药物管理局批准Dupixent用于过敏性真菌鼻炎,治疗6岁及以上的患者,且之前曾经接受过手术.
FDA approves Dupixent for allergic fungal rhinosinusitis in patients 6 and older with prior surgery.
林业发展局批准了治疗6岁及6岁以上有鼻炎手术史的病人的过敏真菌犀牛皮炎(AFRS)的杜比森(Dupix),这是为这一疾病核准的第一种药物。
The FDA has approved Dupixent for treating allergic fungal rhinosinusitis (AFRS) in patients aged 6 and older with a history of sinus surgery, marking the first drug approved for this condition.
根据第3阶段试验的结果,批准结果显示,Dupixent的病人在52周的鼻梁堵塞方面有50%的改善,而安慰剂组为10%。
The approval, based on a phase 3 trial, showed patients on Dupixent had a 50% improvement in sinus blockage at week 52, compared to 10% in the placebo group.
现在该药物已批准用于AFRS和带鼻息肉的慢性鼻炎.
The drug is now approved for both AFRS and chronic rhinosinusitis with nasal polyps.