STAT Plus: Pharmalittle: FDA places hold on Novartis trial for gene therapy; FDA floats plan for combating shortages
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The Food and Drug Administration halted a clinical trial of the Zolgensma gene therapy treatment due to a safety concern found in an animal study, STAT writes. The hold affects a Novartis (NVS) clinical trial that was testing a higher dose administered by spinal injection to older children with spinal muscular atrophy, but this does not affect the already approved treatment of infants and children. The AveXis unit at Novartis informed regulators about findings from an animal study that showed “dorsal root ganglia mononuclear cell inflammation.”
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