智通财经APP获悉，2月21日，葛兰素史克(GSK.US)宣布IL-5单抗Nucala(美泊利珠单抗)的新药上市申请获国家药监局受理，用于作为嗜酸性粒细胞表型慢性阻塞性肺病(COPD)患者的附加维持治疗。如果获得批准，美泊利珠单抗将成为第一个获批用于COPD患者每月给药的生物制剂。
此次申请是基于III期MATINEE研究的积极结果。该研究招募了广泛的COPD患者，包括慢性支气管炎患者、仅肺气肿患者或两者兼而有之的患者。结果显示，与安慰剂组相比，美泊利珠单抗组患者的中度或重度COPD恶化率显著降低，且具有临床意义。目前，COPD以对症治疗为主，方案包括糖皮质激素、支气管扩张剂等，但这无法治本。度普利尤单抗是目前唯一一款获批治疗COPD的生物靶向制剂，给药频率为每两周一次。
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