英国药品和健康产品管理局（MHRA）已批准Kalvista Pharmaceuticals Inc（股票代码：KALV.O）研发的Ekterly®（Sebetralstat）上市，这是全球首款也是目前唯一用于遗传性血管性水肿（HAE）急性发作的口服按需治疗药物。该药物同时满足英国孤儿药认定标准，并获授予长达10年的市场独占期。
作为突破性疗法，Ekterly采用创新的口服给药方式，使患者能够在症状初现时立即自行用药，彻底改变了传统静脉注射或皮下注射的治疗模式。市场独占权的授予突显该药物在罕见病治疗领域的重大临床价值，将为Kalvista在英国市场提供强有力的商业保障。
遗传性血管性水肿作为危及生命的罕见疾病，全球约每5万人中有1例患者。此次获批标志着HAE治疗范式的重大革新，患者首次获得非注射型按需治疗选择。临床数据显示，Sebetralstat能在90分钟内快速缓解症状，为患者提供更便捷高效的治疗方案。
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