The European Medicines Agency (EMA) said on Friday it asking healthcare providers to conduct liver tests on patients treated with Novartis AG's Zolgensma, after recent reports of deaths related to the gene therapy.
Novartis in August reported two patient fatalities due to acute liver failure following treatment with Zolgensma, which is used to treat spinal muscular atrophy.
The EMA said it was looking to issue a warning that doctors promptly assess patients with worsening liver function tests or signs or symptoms of acute liver illness.
A Novartis spokesperson did not have an immediate comment, when contacted by Reuters.
(Reporting by Raghav Mahobe and Manas Mishra in Bengaluru; Editing by Shounak Dasgupta and Shailesh Kuber)