Novartis CEO Vas Narasimhan began his tenure with an inherited scandal. Now he’s got one all his own.
The revelation on Tuesday that AveXis, Novartis’s gene therapy division, submitted falsified data to the Food and Drug Administration is at the very least a blemish on the brief reign of Narasimhan, a rising figure who took over in early 2018 with a promise to change the culture at the Swiss drug maker. But it also threatens to become a much bigger scandal.
At issue is what Novartis knew — and when it knew it — about the manipulation of data used to win approval of its gene therapy for spinal muscular atrophy. According to the FDA, company officials at AveXis were aware of the issues as early as March but didn’t inform regulators until late June. The drug, the first gene therapy for a type of SMA and the most expensive therapy on the market to date, was approved in May.