Novartis AG, which this week announced positive interim trial results for its ex...
- Novartis AG, which this week announced positive interim trial results for its experimental gene therapy for spinal muscular atrophy, on Friday said investigation is underway into whether a second trial death could be related to the treatment.
Novartis has filed for U.S. Food and Drug Administration approval of the gene therapy, Zolgensma, and a decision is expected within weeks. The FDA submission was based on findings from a trial of 15 babies treated with Zolgensma. SMA, which can lead to paralysis, breathing difficulty and death, is the leading genetic cause of death in infants.
“Preliminary findings indicate this occurred in the context of a severe respiratory infection followed by neurological complications in a symptomatic SMA Type 1 patient, and was deemed possibly related to treatment by the investigator,” Novartis spokesman Eric Althoff said in an emailed statement on Friday.
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