Mr. Bouchard was named to the post about a week ago, according to Endpoints News. He replaces Brian Kaspar and Allan Kaspar, who “have not been involved in any operations at AveXis since early May 2019 and are no longer with the company,” Novartis told EndPoints News.
The move comes after the FDA threatened legal action against the company for delaying telling the agency about inaccurate data involving its $2.1 million gene therapy Zolgensma, which treats spinal muscular atrophy.
Novartis learned that some of its employees had manipulated data in the application for Zolgensma in March, but instead of informing the FDA immediately, it conducted its own investigation and submitted results of that probe to the FDA in late June, about one month after Zolgensma was approved by the FDA.
Novartis CEO Vas Narasimhan has defended the company’s decision to keep quiet about the manipulated data, saying patient safety was never threatened.
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