Date: 04-Nov-2019

Novartis says delayed telling FDA of Zolgensma concern due to "mistake"

Novartis scientists learnt months ago about safety concerns surrounding its gene therapy Zolgensma but delayed telling the U.S. Food and Drug Administration (FDA) due to what the Swiss drugmaker said was a "mistake". The FDA on Wednesday placed a partial hold on a Novartis trial of the $2.1 million-per-patient gene therapy after the company informed the agency about a primate study that raised concerns of possible nerve damage or loss. Novartis, under fire since August for not telling regulators about separate data manipulation allegations until after Zolgensma was approved, said scientists at its AveXis unit learnt of the primate study's findings in March.