EMA seeks to issue guidance on liver damage from Novartis gene therapy Zolgensma
The drug won conditional EU approval during early 2020 and it costs more than $2 million per patient;
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Europe: The European Medicines Agency (EMA) said on Friday it plans to issue advice for physicians using Novartis AG's Zolgensma, calling on them to monitor patients for any liver injury after treatment.
The statement follows two deaths due to liver failure after treatment with the gene therapy against spinal muscular atrophy, reported by Novartis in August.
Spinal muscular atrophy is a group of rare genetic disorders which affect the nerve cells and cause muscle wasting and weakness.
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