智通财经APP获悉，GSK(GSK.US)公司今日宣布，美国FDA批准“first-in-class”抗生素Blujepa(gepotidacin)上市，用于治疗单纯性尿路感染(uUTI)的成人及12岁以上青少年患者。作为一款具有全新作用机制的抗生素，Blujepa为克服抗微生物药物耐药性(AMR)提供了有力的新工具。
据悉，Blujepa是一款具有独特作用机制的口服“first-in-class”抗生素。它能够均衡抑制两种不同的II型拓扑异构酶，从而对大多数目标病原体，包括对现有抗生素耐药的菌株产生抗菌活性。由于能够均衡抑制两种酶的活性，细菌需要在两种酶上同时出现突变才能显著降低对Blujepa的敏感性，因此预期产生耐药性的可能性较低。
Blujepa的批准主要基于关键性3期临床试验EAGLE‑2和EAGLE‑3的积极结果。这两项试验中，Blujepa在治疗患uUTI的成年女性(≥40 kg)及青少年患者(≥12岁、≥40 kg)时，与当前标准治疗之一nitrofurantoin相比具有非劣效性。在EAGLE‑2研究中，Blujepa的治疗成功率为50.6%(162/320)，活性对照组为47.0%(135/287)。在EAGLE‑3研究中，Blujepa与活性对照组相比，达到统计学显著优势(单侧p=0.0003)：Blujepa组治疗成功率为58.5%(162/277)，活性对照组为43.6%(115/264)。
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