Novartis scientists learnt months ago about safety concerns surrounding its gene therapy Zolgensma but delayed telling the FDA due to what the company said was a "mistake," as reported Fidelity on Friday.
The FDA recently placed a partial hold on the STRONG trial of the gene therapy after the company informed the agency about a primate study that raised concerns of possible nerve damage or loss.
"Unfortunately, a mistake was made, and this update was not implemented," Novartis said, adding that "we notified investigators and FDA at the end of last week and were notified about the partial clinical hold earlier this week."
"Our discussions with FDA are ongoing and we will work diligently with FDA to identify any additional actions necessary to resume dosing," Novartis said.
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