智通财经APP获悉，澳大利亚监管部门近日批准礼来(LLY.US)的阿尔茨海默病治疗药物Kisunla(donanemab)上市。在百健(BIIB.US)同类药物遭遇审批挫折后，该药成为澳大利亚首个靶向淀粉样蛋白的阿尔茨海默病治疗药物。
礼来周三晚些时候宣布，澳大利亚治疗商品管理局(TGA)已批准Kisunla用于治疗伴有轻度认知障碍和轻度痴呆的特定阿尔茨海默病患者。
此项批准基于礼来TRAILBLAZER-ALZ 2和TRAILBLAZER-ALZ 6两项三期临床试验数据。这两项研究在2500多名早期症状性阿尔茨海默病患者中评估了donanemab的疗效。
今年3月，TGA拒绝批准百健与卫材(ESAIY.US)共同开发的竞争药物Leqembi(lecanemab)，使得礼来在澳大利亚淀粉样蛋白靶向治疗市场获得首发优势。
受此消息影响，lecanemab原研企业瑞典BioArctic(BRCTF.US)股价在欧洲交易时段一度下跌约11%。该公司与卫材合作在北欧地区推广该输液制剂。
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