Swiss Drugmaker Novartis AG on Wednesday said it knew about discrepancies in data it submitted to regulators as it sought approval of its more than $2 million gene therapy Zolgensma, but delayed notifying authorities until it completed an internal investigation.
Novartis faces possible civil or criminal penalties from the U.S. Food and Drug Administration, which said on Tuesday that some data were manipulated from early testing of Zolgensma, the world's most expensive treatment. The FDA said the company was aware of the problems for as much as two months before the drug's U.S. approval.
"We made the decision to progress our quality investigation prior to informing FDA and other regulatory authorities so that we could provide the best information and technical analysis, which we did promptly on completion on June 28," Novartis Chief Executive Vasant Narasimhan said on a conference call with analysts.