智通财经APP获悉，百时美施贵宝(BMY.US)宣布，美国食品药品监督管理局(FDA)已批准颂狄多®(氘可来昔替尼)用于治疗活动性银屑病关节炎(PsA)成人患者。颂狄多是一种口服选择性酪氨酸激酶2(TYK2)抑制剂，也是首个获批用于PsA治疗的TYK2抑制剂。
此次FDA批准是基于关键性POETYK PsA-1与POETYK PsA-2 试验的积极结果。两项研究评估了颂狄多(6mg，每日1次)在治疗活动性银屑病关节炎成人患者中的有效性与安全性。在这两项研究中，颂狄多治疗均带来显著的疾病活动度改善，评估指标包括美国风湿病学会(ACR)20 应答(主要终点)与最小疾病活动度(MDA)应答(关键次要终点)。
资料显示，FDA于2022年首次批准颂狄多用于治疗符合系统治疗或光疗指征的中重度斑块状银屑病成人患者。此后，全球多个监管机构也批准了颂狄多该适应症。颂狄多已在中重度斑块状银屑病治疗领域积累了5 年临床疗效与安全性数据。
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