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Novartis' AveXis changes senior leadership amidst FDA probe

Just over a week after the U.S. Food and Drug Administration launched a probe into Novartis AG and its unit AveXis Inc. for falsifying preclinical data for the gene therapy Zolgensma, AveXis announced that it has changed up its senior leadership team.

AveXis, which developed Zolgensma, appointed Page Bouchard as senior vice president of research and chief scientific officer, according to an Aug. 14 statement from the company. Bouchard's appointment was effective Aug. 5.

Bouchard's position will be a combination of the roles of head of research and development and chief scientific officer, which were previously held by Allan Kaspar and Brian Kaspar, respectively.

Both Brian and Allan Kaspar have not been involved with AveXis since May and are no longer with the company, according to the Aug. 14 statement.

The announcement comes in the midst of a probe from the FDA regarding the manipulation of data provided by AveXis for trials of Zolgensma, a $2.1 million gene therapy for spinal muscular atrophy, a rare genetic childhood disease that impacts the nervous system that controls voluntary movement.

The FDA launched the probe Aug. 6 after finding that data during animal trials for Zolgensma had been manipulated. Novartis was aware of the issue as early as March, but did not notify the FDA until June 28, after Zolgensma's May approval.

Novartis CEO Vas Narasimhan has stood by the company's actions, saying Aug. 7 that Novartis "tried to do the right thing in this instance."

The situation has even drawn the attention of Capitol Hill, where a group of senators has asked the FDA to ensure that the Swiss pharmaceutical giant is held accountable.

The FDA said criminal and civil penalties could come as a result of the probe. The agency has acknowledged that the situation does not impact Zolgensma's benefits.