Novartis acknowledges seven new tumor cases in children treated with its spinal muscular atrophy therapy
Novartis disclosed seven previously unknown instances of tumors found in children receiving its gene therapy for spinal muscular atrophy.
Company disclosure and timing
The drugmaker shared this information with neurologists earlier this week before publicizing it on Thursday. An advocacy group first brought the news to light via a Facebook page. Novartis stated that these cases are currently viewed as a potential safety signal.
Regulatory review and context
SMA Europe issued a statement confirming that regulatory authorities are now examining the specific instances. Since the treatment called Zolgensma received approval in 2019, the company has received nine total reports of tumors in previously treated patients. Of those nine reports, two cases showed evidence linking the tumors to the treatment itself.
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