FDA drops investigation into AveXis’ Zolgensma data manipulation without penalties

LONGMONT — The U.S. Food and Drug Administration stopped its inquiry into data manipulation at Novartis AG (NYSE: NVS) and its subsidiary AveXis over a gene therapy due to be produced in Longmont.

An FDA spokesperson told BizWest there were “objectionable conditions” found in AveXis’ application for the spinal muscular atrophy treatment but didn’t reach the threshold for regulatory action.

The data manipulation was found in animal testing done before any clinical trials were performed in human subjects.

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The FDA publicly announced it would investigate Novartis and AveXis last summer after the companies notified regulators about the data breach after the drug was approved for sale. Novartis CEO Vasant Narasimhan said at the time the company was doing its own internal investigation, but the FDA said it would consider civil or criminal penalties due to the lack of disclosure.

The announcement of the investigation was highly unusual and was considered a warning signal to other pharmaceutical companies, particularly those making expensive therapies. Zolgensma is the most expensive single-dose drug in the world at $2.1 million.

AveXis also fired its two top researchers in May 2019 after allegedly being linked to the manipulation.

Both the FDA and Novartis said the data manipulation did not compromise confidence in the efficacy of the drug.

In a prepared statement, an AveXis spokeswoman said the company has agreed to notify the FDA of any credible suspicion of data tampering within five business days.

“AveXis, together with Novartis’ global quality organization, is implementing a management strategy and quality improvement plan to strengthen the quality culture and to enhance the accuracy, reliability and completeness of quality records and data generated across the company,” she said.

AveXis is in the process of securing federal approval to produce Zolgensma at its 692,000-square-foot plant in Longmont, which could produce between 800 to 1,200 doses of the drug per year and employ about 400 people at full scale.

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