The investigation follows reports of tumour formation in a number of patients who received the treatment. The tumours have been reported in various locations, including the central and peripheral nervous systems, around the spine and in the kidneys.
Zolgensma, developed by Swiss pharmaceutical company Novartis, is one of the world's most commercially successful gene therapies, with annual sales of more than 1.2 billion dollars. Since its approval in 2019, more than 6,000 patients have received the treatment, which is administered as a one-off intravenous infusion.
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