Elevidys™ (delandistrogene moxeparvovec): discontinuation of dosing in non-ambulatory patients following a second overseas case of fatal acute liver failure

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 letter for details. 

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg ↗ (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.