Novartis has replaced two top executives from its AveXis unit following the manipulation of data from early testing of its gene therapy Zolgensma, Reuters reports. Novartis bought AveXis last year, Bloomberg notes.
The US Food and Drug Administration announced last week that it had learned of that data manipulation, but concluded that the therapy should remain on the market. The agency approved Zolgensma — which has a list price of $2.1 million — in May for the treatment of spinal muscular atrophy in children who are under the age of two. But the FDA noted that Novartis was aware of the data manipulation in March, months before the drug was approved. This, Bloomberg says, has raised the ire of lawmakers in Washington, some of whom have called for investigations.
According to Reuters, AveXis's Chief Scientific Officer Brian Kaspar and his brother Allan Kaspar, the senior vice president of research and development at AveXis, have not been involved in any of the unit's operations since early May and Page Bouchard has taken over their roles. Reuters adds that a few other scientists have also left the company, but that Novartis has not disclosed who was behind the data manipulation.