The Food and Drug Administration has halted a clinical trial of Novartis’ Zolgensma gene therapy due to a safety concern found in an animal study, the company said Wednesday.
The hold affects the Novartis clinical trial known as STRONG, which was testing a higher dose of Zolgensma administered by spinal injection to older children with spinal muscular atrophy (SMA). It does not affect the already approved treatment of infants and children.
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The headline is poorly worded. The FDA didn’t halt the study because they were concerned about the safety of the animals. Novartis isn’t Santa Cruz Biotechnology.