FDA places no penalties on Novartis after Zolgensma data manipulation investigation

pharmafile | April 2, 2020 | News story | Business Services FDA, Novartis, regulators 

The FDA has concluded its investigation into Novartis and its data manipulation of the gene therapy Zolgensma, and has decided to place no penalties on the company.

In a statement, the FDA said it has “completed its review of the information and records of the inspection, the evidence collected, and the firm’s responses as well as the corrective actions.”

The FDA has also classified its review of the case as “Voluntary Action Indicated”. This means that invisitgators found objectionable issues but as it did not meet the threshold it will not recommend regulatory action or enforcement at this time.

The regulator reiterated that although there was some early data manipulation with Zolgensma, a multi-million dollar treatment for spinal muscular atrophy, the treatment is still safe and effective.

In response the company said it was pleased with the outcome and reiterated it commitment to transparency and data integrity in its dealings with regulatory agencies.

The case began in August 2019, when it was revealed that there had been manipulation of the data in preclinical studies of the treatment when it was under development by AveXis, which is now a subsidiary of Novartis. The FDA was informed of this manipulation by the companies themselves and Novartis later established a policy to notify the FDA within five days of a discovery of any data manipulation.

Conor Kavanagh

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