Novartis admits to ‘mistake’ after partial clinical hold placed on Zolgensma trial
Novartis on Wednesday said that the FDA placed a partial hold on intrathecal clinical trials of its gene therapy Zolgensma (onasemnogene abeparvovec-xioi) for spinal muscular atrophy (SMA) patients based on findings in a small preclinical animal study.
On Thursday, a Novartis spokesperson told Focus that a draft report of the preclinical safety findings was presented to the AveXis safety management team last March and the company “determined at that time that the safety finding should be included in the annual update of the investigator brochure planned for September 2019. Unfortunately, a mistake was made, and this update was not implemented.”
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