Faced with another ethics scandal, Novartis CEO Vas Narasimhan assures analysts they tried to do 'the right thing'
Novartis’ new gene therapy subsidiary AveXis has put up a red flag regarding the manipulation of data used in its quest to obtain an FDA approval for the gene therapy Zolgensma, recently OK’d for lethal cases of spinal muscular atrophy and sold now for $2 million. And the FDA has responded by opening a probe while threatening possible civil and criminal sanctions related to the world’s most expensive drug.
The FDA issued a statement from CBER’s Peter Marks saying that “the agency was informed by AveXis Inc., the product’s manufacturer, about a data manipulation issue that impacts the accuracy of certain data from product testing performed in animals submitted in the biologics license application (BLA) and reviewed by the FDA.”
We are also aware that AveXis became aware of the issue of the data manipulation that created inaccuracies in their BLA before the FDA approved the product, yet did not inform the FDA until after the product was approved. The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties.
Novartis stock dropped 2.8% on Tuesday.
Basic subscription required
Unlock this story instantly and join 57,500+ biopharma pros reading Endpoints daily — and it's free.