近日,阿斯利康宣布,FDA拒绝了旗下药物Andexxa的完全批准。值得一提的是,该药已于去年12月在中国申报上市。2018年,Andexxa在美获得FDA加速批准上市,次年拿下欧盟有条件批准,用于治疗阿哌沙班和利伐沙班导致的急性出血并发症,是首个也是目前唯一能够特异性逆转FXa抑制剂活性并实现止血的治疗方法,在临床上可谓是一款“救命药”。2021年,阿斯利康以390亿美元的价格收购罕见病巨头...
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