STAT News is reporting:

“AveXis, the gene therapy subsidiary of Swiss pharma giant Novartis (NVS), was aware of “data manipulation” involving its Zolgensma gene therapy for spinal muscular atrophy before it was approved in May, but did not inform the Food and Drug Administration until later, the agency said Tuesday.”

Zolgensma is the first gene therapy for a type of spinal muscular atrophy, a lifesaving treatment for infants that will also be the most expensive drug in the world. It was developed by AveXis, which was acquired by Novartis in April 2018.

Had the agency known about the manipulation, it would have delayed the approval of Zolgensma, according to Dr. Wilson Bryan, the director of the FDA division that reviewed Novartis’s gene therapy.

Since 2000, Novartis has paid $1,221,184,386 in violations and offenses that include kickbacks and bribery, off-label and unapproved promotion of medical products and other penalties.

The FDA is currently reviewing the data issue which may lead to “civil or criminal penalties,” according to a statement.