欧盟批准Dupixent用于治疗抗组胺药不反应的青少年和成年人的慢性疹.
The EU approved Dupixent for chronic hives in teens and adults unresponsive to antihistamines.
欧盟委员会批准Dupixent (dupilumab) 治疗12岁及以上的成人和青少年中中度至严重的慢性自发性疹,这些患者对抗组胺剂没有反应,也没有使用抗IgE治疗.
The European Commission has approved Dupixent (dupilumab) for moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 and older who don’t respond to antihistamines and haven’t used anti-IgE treatments.
这是十多年来欧盟首个针对CSU的新的定向疗法。
It’s the first new targeted therapy for CSU in the EU in over ten years.
批准基于3期试验数据,显示在Dupixent与抗组胺药物一起使用时,疹和的显著减少.
Approval is based on Phase 3 trial data showing significant reduction in hives and itching when Dupixent is added to antihistamines.
患者在24周内有更好的疾病控制,并有更高的完整回复率。
Patients had better disease control and higher complete response rates at 24 weeks.
毒品区块IL-4和IL-13是发炎的主要驱动因素。
The drug blocks IL-4 and IL-13, key drivers of inflammation.
共同的副作用包括注射现场反应、结膜炎和口服疹。
Common side effects include injection site reactions, conjunctivitis, and oral herpes.
杜皮森特目前已在欧盟批准用于治疗七种炎症病,在美国,日本和其他国家也可用于治疗CSU.
Dupixent is now approved for seven inflammatory conditions in the EU and is also available for CSU in the U.S., Japan, and other countries.