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# FDA Partial Hold on Novartis/AveXis AVXS-101 Trials
- URL: https://www.fdaweb.com/fda-partial-hold-on-novartis-avexis-avxs-101-trials/
- Published: 2019-10-30T12:00:00.000Z
- Updated: 2026-09-14T15:51:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145376

FDA has placed a partial hold on clinical trials for intrathecal administration of AVXS-101 following an AveXis communication to health authorities and clinical trial investigators based on findings from a small, AveXis-initiated pre-clinical study in which animal findings showed dorsal root ganglia mononuclear cell inflammation, sometimes accompanied by neuronal cell body degeneration or loss. Zolgensma (onasemnogene abeparvovec-xioi), also known as AVXS-101 intravenous administration, is not affected and remains available in the U. S., Novartis [says](https://www.novartis.com/news/media-releases/novartis-announces-avxs-101-intrathecal-study-update?ref=fdaweb.com)*.* Also unaffected are AVXS-101 intravenous clinical trials.

AveXis is studying AVXS-101 intrathecal administration in patients with spinal muscular atrophy Type 2\. Novartis says it is working with FDA to determine next steps to release the partial hold and resume dosing in the AVXS-101 intrathecal trials.