Novartis earlier acknowledged Zolgensma data errors to FDA but blamed them on poor reporting

In an inspection of the Illinois manufacturing facility for Novartis’ Zolgensma earlier this year, a team of top FDA officials met with AveXis staff. Although the assay that is now at the center of Novartis scandal was discussed, the FDA found the whole situation “unremarkable.”

That is because the AveXis team, which included the now-dispatched Allan Kaspar, explained away errors. They told the FDA that there had been some issues with the original assay for determining the potency of the gene therapy, but that they had been corrected. Poor reporting was the culprit, they said, and a new procedure was put in place with “new forms for documentation and to clarify and standardize.”