Novartis Says Two Children Treated With Gene-Therapy Zolgensma Died
12 Agosto 2022 - 06:35AM
Dow Jones News
By Maitane Sardon
Novartis AG said that two children who received its gene therapy
for a neuromuscular disease died after the treatment.
The patients developed acute liver failure about five to six
weeks after being administered the gene therapy, Zolgensma, which
is used to treat spinal muscular atrophy, a muscle-wasting
condition.
"While acute liver failure is a known adverse event, these are
the first fatal cases of acute liver failure," the Swiss pharma
major said in an emailed statement Friday.
Novartis said the children had also received corticosteroids,
which are used alongside Zolgensma to prevent complications that
can lead to severe liver damage.
The deaths occurred in Russia and Kazakhstan, Novartis said.
"Pending health authority review and approval, the Zolgensma
label will be updated to inform prescribers that fatal acute liver
failure has been reported," Novartis said.
Write to Maitane Sardon at maitane.sardon@wsj.com
(END) Dow Jones Newswires
August 12, 2022 05:20 ET (09:20 GMT)
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