NEW YORK, Aug 6 (Reuters) - The U.S. Food and Drug Administration said on Tuesday that some data from early testing of Novartis’ more than $2 million gene therapy Zolgensma was manipulated, but the agency believes the treatment should remain on the market.
The FDA said it is carefully assessing the situation. It said the manipulation involves the accuracy of certain data from product testing performed in animals, which was used by the manufacturer to support the development of its production process.
Novartis’ Avexis unit informed the FDA of the data manipulation on June 28, the regulator said. Novartis acquired the therapy’s maker last year.
The FDA said it is aware that Avexis knew about the data manipulation before the treatment’s approval, and plans to take action against the company including possible civil or criminal penalties.
The FDA said the manipulated data does not change its positive assessment of information from human clinical trials. It said it will continue to evaluate the integrity of the product testing data used in the development of Zolgensma’s manufacturing process.
Zolgensma - the world’s most expensive drug - was approved in late May. The gene therapy treats spinal muscular atrophy (SMA), the leading genetic cause of death in infants. (Reporting by Michael Erman Editing by Bill Berkrot)