其 他 安 全 警 示
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| Singapore: Elevidys™ (delandistrogene moxeparvovec): Acute liver failure following Elevidys™ treatment (English only) |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to update healthcare professionals that a patient with Duchenne Muscular Dystrophy has passed away, 12 weeks after commercial treatment with Elevidys™.
Elevidys™ is indicated for the treatment of ambulatory patients ≥4 years of age with Duchenne muscular dystrophy (DMD) who have a confirmed mutation in the DMD gene. It is also indicated for the treatment of patients ≥4 years of age with DMD who are non-ambulatory and have a confirmed mutation in the DMD gene. The DMD indication in non-ambulatory patients is approved under accelerated approval based on expression of delandistrogene moxeparvovec micro-dystrophin in skeletal muscle observed in treated patients. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Elevidys™ is not registered in Singapore but is available locally for patients under HSA’s Special Access Route. Acute liver injury is a known side effect highlighted in the Elevidys™ prescribing information. Acute liver failure leading to death represents a severity of acute liver injury not previously reported in over 800 patients treated in clinical trial and post-marketing settings. Roche is still assessing this safety issue and will update the prescribing information as appropriate.
Healthcare professionals are advised to counsel patients about the risks and benefits of Elevidys™. In case of acute serious liver injury, it is recommended to monitor liver parameters and consult with a specialist as per Elevidys™ prescribing information.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/elevidys--(delandistrogene-moxeparvovec)--acute-liver-failure-following-elevidys--treatment
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Mar 25, 2025
Issued at HKT 15:15
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