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A second death in a trial of Novartis' gene therapy, Zolgensma, for type 1 spinal muscular atrophy is under investigation, Reuters reports. Type 1 SMA leads to paralysis and breathing trouble.

Reuters adds that the firm recently reported positive interim trial results and filed for US Food and Drug Administration approval based on a trial of 15 babies given Zolgensma. Reuters notes that a decision is expected within weeks.

The interim results — based on 22 infants — showed patient improvement in motor skills, according to Reuters, including the ability to sit up.

However, Reuters adds that a second death occurred in the trial. At trial investigator and an independent monitor found that the first death was unrelated to the treatment, but this second one could be treatment related and adds that an investigation is ongoing. "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 spokesperson Eric Althoff tells Reuters in a statement.