Roche and Sarepta Therapeutics have jointly decided to voluntarily and temporarily pause all new orders of delandistrogene moxeparvovec (ELEVIDYS), the gene therapy for Duchenne muscular dystrophy. This pause applies to Sarepta’s distribution in the United States and Roche’s efforts in countries outside the U.S.

This decision follows Sarepta Therapeutics’ recent safety update and an informal request from the U.S. Food and Drug Administration (FDA) to halt shipments of ELEVIDYS, in light of emerging concerns—most notably, the reported death of an adult non-ambulant individual living with Limb-Girdle muscular dystrophy.

While ELEVIDYS is not currently approved for use in Canada, and therefore does not have a direct impact on Canadians living with Duchenne, we recognize the emotional weight of this news. If you have any questions or concerns, we encourage you to contact your clinical care team for guidance and support.

Our heartfelt thoughts are with the families grieving the loss of their loved one, and with those who may feel discouraged by this development. Roche and Sarepta remain committed to working closely with the FDA and regulatory authorities worldwide to determine the appropriate next steps.

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Want to know more about Duchenne Research?

Scientists and medical experts have been tirelessly pursuing diverse approaches to defeat Duchenne muscular dystrophy. From tackling the root cause to alleviating symptoms, the field of research is vast and promising. Explore the various strategies being developed and tested, and gain insights into the future of muscular dystrophy treatment: