Novartis announces AVXS-101 intrathecal study update
[caption id="attachment_9277" align="aligncenter" width="747"] Press Release[/caption]
- FDA placed a partial hold on AVXS-101 intrathecal clinical trials for SMA patients based on findings in a small pre-clinical animal study
- Adverse events that might be expected from the pre-clinical findings?have not been seen in a thorough review of human safety data from all available sources to date
- Zolgensma?(onasemnogene abeparvovec-xioi) also known as?AVXS-101 intravenous administration is not impacted and remains available in the US
- Novartis is working with FDA to determine next steps to release partial hold and resume dosing in the AVXS-101 intrathecal trials