FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Temporarily Halts Zolgensma Trials for Spinal Injection

Nov. 11, 2019
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The FDA has placed a partial hold on clinical trials on Zolgensma (onasemnogene abeparvovec-xioi) for spinal injection, Novartis announced.

The hold is based on findings from a small, pre-clinical study initiated by its AveXis subsidiary, in which animal findings showed dorsal root ganglia mononuclear cell inflammation, sometimes accompanied by neuronal cell body degeneration or loss.

Novartis said that the hold at the enrollment stage will not impact marketed Zolgensma or clinical trials studying the drug for IV administration.

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