Elevidys™ (delandistrogene moxeparvovec): Acute liver failure following Elevidys™ treatment

A Dear Healthcare Professional Letter has been issued by Roche Singapore Pte Ltd to update healthcare professionals that a patient with Duchenne Muscular Dystrophy in the United States has passed away, 12 weeks after commercial treatment with Elevidys™. 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 letter for details.

Healthcare professional, Industry member, Therapeutic Products
Published:

Dear Healthcare Professional Letters

25 Mar 2025

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

Step 1: Scroll down to the bottom navigation panel of the HPP web page. Under the Healthcare Professionals section, expand the dropdown option for ‘Healthcare Professional Portal’ and select your profession. You will be redirected to the specific HPP web page to log in.

Step 2: Click on the Restricted Content icon on the left panel of the web page and log in via SingPass.

Step 3: Click on the MOH Alert icon under the ‘Applications’ section.

Step 4: Click on the Drug Alert tab to view the DHCPLs.