- Novartis confirmed that brothers Brian Kaspar and Allan Kaspar, who ran a gene-therapy subsidiary at the drugmaker accused by federal regulators of manipulating data, are no longer with the company.
- The Food and Drug Administration said the Swiss drugmaker could face criminal or civil penalties for allegedly providing inaccurate data on Zolgensma, which the agency approved in late May.
- The drug, a potentially life-saving treatment for children with a severe form of spinal muscular atrophy, costs $2.1 million.
The sibling scientists who ran Novartis’ gene therapy unit, which allegedly offered inaccurate data in getting the world’s priciest drug approved, are no longer working for the Swiss drugmaker.
Brian Kaspar and Allan Kaspar, brothers who held the titles of chief scientific officer and head of research at Novartis subsidiary AveXis, respectively, “have not been involved in any operations at AveXis since early May 2019 and are no longer with the company,” Novartis said Wednesday in a statement to CBS MoneyWatch.
The brothers became employees of Novartis after the company last year bought AveXis for $8.7 billion.
Novartis would not confirm nor deny reports that CEO Vasant Narasimhan fired the pair shortly after learning about the allegations of data manipulation involving Zolgensma. Approved by the U.S. Food and Drug Administration in May, the treatment is for children with a severe form of spinal muscular atrophy and costs a staggering $2.1 million.
The FDA earlier this month said it approved Zolgensma on May 24,of a “data manipulation issue that impacts the accuracy of certain data from product testing performed in animals.”
AveXis, the maker of Zolgensma, discovered the data was faulty before its approval, but waited until after it had gotten federal clearance to inform the FDA, the agency said. The FDA said it expects Zolgensma to remain on the market.
Novartis did not deny the allegations, but defended its product and handling of the situation overall.
“We maintain that the totality of the evidence demonstrating the product’s effectiveness and its safety profile continue to provide compelling evidence supporting an overall favorable benefit-risk profile,” the company said in a statement after the FDA action. “At no time during the investigation did the findings indicate issues with product safety, efficacy or quality.”
The company is working with the FDA to update its application and “address any quality gaps,” Novartis added.