FDA says Novartis gene therapy drug application contains manipulated data

Aug 06, 2019

The U.S. Food and Drug Administration announced that some data from early testing of Novartis gene therapy Zolgensma was manipulated. Still the FDA says the treatment should stay on the market as it assess the situation.

According to the organization, the manipulation involves the accuracy of data from product testing performed in animals and that concerns were limited to a small portion of product testing data. The manipulated data does not affect the FDA's assessment on the trials performed on humans.

On June 28, Novartis’ Avexis unit, which manufactures the product, informed the FDA of the data manipulation. Avexis was aware of the data manipulation before its initial approval on May 24 and as such, the FDA still plans on taking action against the company.

Read the full FDA statement.