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Aimmune制药在2018 EAACI上公布AR101治疗花生过敏的全新临床数据

2018-05-29 MedSci MedSci原创

Aimmune制药是一家开发可能危及生命的食物过敏疗法的生物制药公司,Aimmune在2018年于德国慕尼黑举行的过敏、哮喘和免疫学大会(EAACI)上报告了AR101治疗花生过敏的关键性III期PALISADE临床试验的其他结果。Aimmune先前在4-17岁年龄组的试验达到了预先指定的主要和次要临床终点,而本次公布的数据提供了其他分析,包括在研究中接受治疗的成年人数据。

Aimmune制药是一家开发可能危及生命的食物过敏疗法的生物制药公司,Aimmune2018年于德国慕尼黑举行的过敏、哮喘和免疫学大会(EAACI)上报告了AR101治疗花生过敏的关键性IIIPALISADE临床试验的其他结果。Aimmune先前在4-17岁年龄组的试验达到了预先指定的主要和次要临床终点,而本次公布的数据提供了其他分析,包括在研究中接受治疗的成年人数据。

花生过敏,花生是重要的食物过敏原,会引起极其罕见的过敏症。花生过敏的症状包括血压降低、面部和喉咙肿胀,这些都会阻碍呼吸,从而导致休克。

PALISADE共招募了5544-55岁患者(4-17岁占90%)。经过大约一年的治疗后,该试验达到了其主要终点,因为67%的经AR101治疗患者能够耐受至少600mg剂量的花生蛋白,而安慰剂组患者的这一比例仅仅为4%(p <0.00001)。主要终点治疗组间差异的95%置信区间(CI)下限为53%,大大超过了预先设定的15%阈值(p <0.00001)。

基于这些结果,Aimmune计划在2018年底之前向美国食品和药物管理局(FDA)提交AR101的生物制剂许可申请(BLA),随后向欧洲药品管理局(EMA)提交上市授权申请(MAA)。在美国,AR101已经获得FDA授予的快速通道资格以及突破性疗法认定。


原始出处:

http://www.firstwordpharma.com/node/1568393?tsid=4#axzz5GkzHmywR

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    2018-08-13 windight
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    2019-04-18 Homburg
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    2018-05-31 quxin068
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