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  • EMA seeks to issue...

EMA seeks to issue guidance on liver damage from Novartis gene therapy Zolgensma

Ruchika SharmaWritten by Ruchika Sharma Published On 15 Jan 2023 6:45 AM  |  Updated On 15 Jan 2023 6:45 AM
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy
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The drug won conditional EU approval during early 2020 and it costs more than $2 million per patient

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.

The advice for healthcare professionals has yet to be approved by further expert panels at EMA, which typically takes a few weeks.

Novartis said it had notified health authorities of the deaths and sent letters to update healthcare providers on liver safety in markets including the United States in August.

In Europe, however, such letters had been the subject of discussions with EMA, but Novartis would soon be cleared to send them in EU member states, it added.

The EMA said that if patients do not respond adequately to treatment with corticosteroids, treating physicians should consult specialists and consider adjusting the corticosteroid regimen.

Infusion drug Zolgensma competes with Roche's oral drug Evrysdi and Biogen's spinal injection Spinraza.

It won conditional EU approval during early 2020 and it costs more than $2 million per patient.

Read also: Novartis gets CDSCO Panel nod to market anticancer drug Trametinib and Dabrafenib for additional indication

novartisnovartis newseuropean medicine agencyliver damagegene therapyZolgensmaspinal muscular atrophycorticosteroids
Source : Reuters
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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