Other safety alerts
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| Singapore: Elevidys™ (delandistrogene moxeparvovec): discontinuation of dosing in non-ambulatory patients following a second overseas case of fatal acute liver failure |
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Health Sciences Authority (HSA) announces that a Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to advise healthcare professionals to suspend dosing with Elevidys™ (delandistrogene moxeparvovec) in non-ambulatory Duchenne Muscular Dystrophy (DMD) patients, irrespective of age. This is based on a reassessment of the benefit versus risk of Elevidys™, following the overseas report of acute liver failure and death of a second non-ambulatory DMD patient (aged 15 years), 11 weeks after clinical trial treatment with Elevidys™.
Healthcare professionals are advised to immediately stop dosing non-ambulatory DMD patients with Elevidys™.
The package insert (as approved in the United States of America and in other countries where the non-ambulatory indication is approved) will be amended to remove the indication for treatment in non-ambulatory patients.
Please refer to the following website in HSA for details:
http://www.hsa.gov.sg/announcements/dear-healthcare-professional-letter/elevidys--(delandistrogene-moxeparvovec)--discontinuation-of-dosing-in-non-ambulatory-patients-following-a-second-overseas-case-of-fatal-acute-liver-failure
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by HSA, and was posted on the Drug Office website on 25 Mar 2025.
Ends/Tuesday, Jun 24, 2025
Issued at HKT 14:30
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