A British baby's death this year after getting Novartis's gene therapy...
ZURICH - A British baby’s death this year after getting Novartis’s gene therapy Zolgensma was not caused by a toxic drug reaction, the Swiss drugmaker said, allaying concerns over the $2.1 million-per-patient treatment’s risks.
Novartis has been investigating the death of a 6-month-old patient in a European trial. Novartis executives now say investigators and the coroner concluded the immediate cause was brain damage from oxygen deprivation after respiratory distress, not brain damage from a toxic drug agent. “We had been concerned about the potential... that Zolgensma might have been causing brain inflammation,” said AveXis Chief Executive Dave Lennon. “In this case, the original diagnosis, and that association, hasn’t held true.”
While Novartis replaced AveXis employees and has since promised to speed disclosures of problematic data, the FDA left Zolgensma on the market after concluding it is safe and effective.
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