Novartis, the Swiss drug giant under fire for using manipulated data in a recent drug approval, has fired two top scientists at its AveXis affiliate involved in the project, according to a person familiar with the matter.
Brian Kaspar and Allan Kaspar, brothers who were previously the chief scientific officer and the head of research at AveXis, respectively, "have not been involved in any operations at AveXis since early May 2019 and are no longer with the company," Novartis said in a statement Wednesday.
Though Novartis didn't specify the reason for their departure, they and a few other scientists were fired in connection with data manipulation brought to light last week by the Food and Drug Administration, according to the person, who declined to be named because an investigation is ongoing.
The FDA threatened to take civil or criminal action against Novartis, saying Aug. 6 the drugmaker used data it knew was inaccurate in its application for a $2.1 million gene therapy, Zolgensma, which was approved in May. Zolgensma treats the rare and devastating childhood disease spinal muscular atrophy and is considered a breakthrough as one of the first gene therapy drugs approved in the U.S.
Novartis and the FDA both said the manipulation didn't affect the evidence supporting Zolgensma's safety and efficacy and that the drug should remain on the market. The data in question involved a way of testing the potency of the drug during its early development, Novartis said.
The FDA said its review of the therapy may have been extended if it had the information before approval, on May 24.
Novartis Chief Executive Officer Vas Narasimhan said the company immediately began investigating the issue when it uncovered it and waited to tell the FDA until it had "the best information and technical analysis, which we did promptly on completion on June 28."
Novartis announced it would acquire AveXis in April of last year for $8.7 billion. The company said the data manipulation occurred on a potency test that was discontinued in June 2018, and it didn't discover it until mid-March of this year.
The Kaspar brothers didn't immediately respond to messages seeking comment. According to a regulatory filing, Allan Kaspar joined AveXis in January 2014 and served as vice president of research and development. Brian Kaspar provided consulting services to AveXis from January 2014 to December 2015 and became chief scientific officer in June 2015. He joined AveXis' board in October 2013.
据一位知情人士透露，瑞士制药巨头诺华( Novartis )最近在一项药品审批中使用了操纵数据，该公司已解雇了参与该项目的 AveXis 子公司的两名顶级科学家。
诺华（Novartis）周三在一份声明中表示：“自2019年5月初以来，分别担任艾维斯首席科学官和研究主管的 Brian Kaspar 和 Allan Kaspar 兄弟没有参与艾维斯的任何业务，也不再参与艾维斯的任何业务。”
这位知情人士称，尽管诺华（Novartis）没有说明离职的原因，但他们和其他一些科学家上周被美国食品和药物管理局( Food and Drug Administration )曝光的数据操纵事件，导致他们被解雇。
FDA 威胁要对诺华（Novartis）采取民事或刑事行动，说8月6日，这家制药商在申请210万美元的基因治疗时使用的数据是不准确的。Zolgensma 治疗儿童罕见的毁灭性脊髓性肌萎缩症，被认为是美国首批基因治疗药物之一。
诺华（Novartis）和 FDA 都表示，这种操纵并没有影响佐尔甘斯曼的安全性和有效性的证据，而且该药物应该继续上市。诺华（Novartis）说，这些数据涉及一种在药物早期开发过程中检测其效力的方法。
诺华（Novartis）首席执行官 Vas Narasimhan 说，该公司在发现问题时立即开始调查，并等待告知 FDA ，直到“最好的信息和技术分析，我们在6月28日完成后立即进行了分析。”
诺华（Novartis）公司宣布，将于去年4月以87亿美元收购 AveXis 。该公司表示，数据操纵发生在2018年6月停止的效力测试上，直到今年3月中旬才发现。
卡斯帕兄弟没有立即回应寻求置评的消息。根据一份监管申报文件， Allan Kaspar 于2014年1月加入 AveXis ，担任研发副总裁。Brian Kaspar 于2014年1月至2015年12月为 AveXis 提供咨询服务，并于2015年6月成为首席科学官。2013年10月，他加入了 AveXis 的董事会。