AveXis’s problems date back farther than we thought

Before the AveXis data manipulation issue that would blossom into a proper scandal for parent company Novartis, the gene therapy developer had already run afoul of FDA regulations.

As STAT’s Ed Silverman reports, FDA inspectors noted that AveXis discovered issues with its mouse test back in October 2018. The problem stemmed from AveXis’s use of “a non-validated spreadsheet” to calculate preclinical data, according to the FDA, and inspectors left the site satisfied that the company had righted its wrongs.

That reads a bit ominous now. It was manipulated data from that same site that ended up getting submitted to the FDA. Novartis executives got wind of the problem some time in May but decided not to tell the FDA until late June. And in August, after all this came to light, they insisted it wasn’t a systemic issue at AveXis.

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