生物制药公司Insmed近日宣布，其针对非结核分枝杆菌（MAC）肺病研发的Arikayce®（阿米卡星脂质体吸入混悬液）在三期B阶段Encore临床试验中取得突破性顶线数据。该研究结果显示，与单纯背景方案相比，Arikayce®联合背景方案在难治性MAC肺病患者中展现出显著临床获益。
此次公布的积极数据进一步验证了Arikayce®作为首个获批用于MAC肺病治疗的吸入式抗生素的疗效。研究详细结果将提交至即将召开的国际医学会议进行专题报告，同时计划向全球监管机构递交扩展适应症的申请资料。
值得注意的是，MAC肺病作为慢性进行性肺部感染疾病，近年来全球发病率持续攀升。Arikayce®若成功扩大适应症，有望为现有治疗手段有限的患者群体提供新的治疗选择。公司表示将加速推进该药物的商业化布局，同步开展真实世界证据收集工作。
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