智通财经APP获悉，中国国家药监局药品审评中心官网近日公示显示，武田(TAK.US)申报的1类新药奥博雷通片(oveporexton，TAK-861片)的上市申请拟纳入优先审评，适用于治疗16岁及以上1型发作性睡病(NT1)患者。公开资料显示，这是武田研发的一款口服选择性食欲素2型受体(OX2R)激动剂。该产品针对NT1适应症的两项3期关键性研究已经达到所有主要和次要终点。

发作性睡病I型(NT1)是一种罕见的慢性中枢神经系统疾病，由于患者的食欲素神经元大量缺失，导致大脑和脑脊液中食欲素神经肽水平低下。NT1患者常常有日间过度思睡(EDS)、猝倒(即肌肉张力突然丧失)、夜间睡眠紊乱、入睡前和清醒前幻觉以及睡眠瘫痪等临床症状。

奥博雷通片是一种在研选择性OX2R激动剂，可选择性地刺激OX2R以恢复其信号传导，并改善因食欲素缺乏而导致的NT1。2025年7月，武田宣布奥博雷通片的两项针对NT1的3期研究达到所有主要和次要终点。

主要和次要终点中测量的指标均显示，患者在觉醒、日间过度思睡、猝倒、保持注意力的能力、整体生活质量和日常生活功能方面有显著的改善且具有统计学意义，所观察的一系列症状的各项临床指标均已改善至接近正常范围。

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