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诺华终止中阶Fabhalta试验,该试验针对严重肾脏疾病Novartis ends mid-stage Fabhalta trial targeting serious kidney condition

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2026年6月23日,在美国加利福尼亚州圣迭戈举行的2026年BIO国际大会上,诺华展台及其标志。该大会是制药和生物技术领域领导者的会议。路透社/迈克·布莱克/资料图片A view of the Novartis booth and logo at the BIO International Convention 2026, a meeting of pharmaceutical and biotechnology leaders in San Diego, California, U.S. June 23, 2026. REUTERS/Mike Blake/File Photo

瑞士制药公司诺华因“战略考量”终止了一项中阶研究,该研究测试其药物Fabhalta在患有严重肾脏疾病患者中的应用,这是根据联邦临床试验登记册的信息。

该试验正在评估这种口服药物在加入标准医疗护理的情况下,是否对狼疮性肾炎的治疗安全有效。狼疮性肾炎是由自身免疫性疾病狼疮引起的严重肾脏炎症。

Swiss drugmaker Novartis has terminated a mid-stage study testing its drug Fabhalta in patients with a serious kidney condition, citing "strategic considerations", according to a federal clinical trials registry.

政府数据库显示,该数据库最后更新于10月15日,诺华决定在完成第一部分后终止该研究。该数据库未给出其他解释,也没有说明安全性或有效性是否起到了作用。

The trial was evaluating whether the oral medication was safe and effective for treating lupus nephritis when added to standard medical care Lupus nephritis is a severe inflammation of the kidneys caused by the autoimmune disease lupus The government database, last updated on October 15, shows Novartis decided to conclude the study after completing the first part It gives no other explanation and does not say whether safety or effectiveness played a role Endpoints News reported the development earlier on Friday Novartis did not immediately respond to a Reuters request for comment The US FDA first approved Fabhalta in 2023 for a rare blood disorder called PNH.

Endpoints News在周五之前就报道了这一发展。诺华未能立即回应路透社的置评请求。

美国FDA最初于2023年首次批准Fabhalta用于一种罕见的血液疾病——夜间血红蛋白尿症(PNH)。此后,它已获批用于两种肾脏疾病:IgA肾病和C3球蛋白病。

It has since been approved for two kidney diseases, IgA nephropathy and C3 glomerulopathy