Novartis' Zolgensma study halted by FDA amid safety questions

U.S. regulators have halted a trial of Novartis’s Zolgensma treatment after an animal study raised safety concerns, the company said on Wednesday, in a setback for the drugmaker’s plan to expand its use to older patients. The U.S. Food and Drug Administration’s partial hold on the so-called STRONG trial impacts patients aged up to five with spinal muscular atrophy (SMA) who were to receive a higher dose of the gene therapy via a spinal infusion. The hold was issued after Novartis told health authorities about the animal study’s findings that showed dorsal root ganglia (DRG) mononuclear cell inflammation, a neurological condition sometimes accompanied by nerve damage or loss.