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.
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.
Comments are closed.