Kalvista Pharmaceuticals Inc获英国MHRA批准EKTERLY,开创遗传性血管性水肿首个口服按需疗法

华尔街洞察
Jul 16

Kalvista Pharmaceuticals Inc宣布,英国药品和医疗产品监管机构(MHRA)已授予EKTERLY®(sebetralstat)营销授权,这款创新口服药物专为遗传性血管性水肿(HAE)发作设计。EKTERLY由此成为英国首个且唯一一款HAE口服按需疗法。 该药物在Kalvista的Salisbury实验室研发,符合MHRA孤儿药认定标准,确保了长达10年的市场独占权。这一里程碑紧随美国FDA近期批准用于12岁及以上青少年和成人之后,进一步加速了Kalvista的全球快速推出战略。 此外,营销授权申请已提交至欧盟、日本及其他关键市场。

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