The FDA said Novartis used data it knew was inaccurate in its application for its $2.1 million gene therapy Zolgensma, and the agency is threatening to take criminal action against the drugmaker.
On May 24, the FDA approved Zolgensma, a gene therapy for spinal muscular atrophy. About a month later, the agency was informed of a data manipulation issue by AveXis, the gene therapy subsidiary of Novartis.. The error hindered the accuracy of some data obtained when the product was being tested on animals, the FDA said.
"The FDA is carefully assessing this situation and remains confident that Zolgensma should remain on the market," the FDA stated.
The FDA said that it is only concerned about a small portion of the product data contained in the marketing application. The agency said the error, to date, doesn't affect its positive assessment of the information from the human clinical trials.
The FDA said that AveXis became aware of the data manipulation before the FDA approved the product, but waited until after the product was approved to inform the agency.
"The agency will use its full authorities to take action, if appropriate, which may include civil or criminal penalties," the FDA said.