Elevidys (delandistrogene moxeparvovec) is a gene therapy developed for Duchenne muscular dystrophy (DMD). It was first approved in the United States and has subsequently received regulatory approvals in several other countries. However, Elevidys is not currently approved in the European Union.
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In Which Countries Is Elevidys Approved?
As of 2026, Elevidys is approved in eight countries:
- United States
- Japan
- Israel
- United Arab Emirates
- Oman
- Bahrain
- Qatar
- Kuwait
The approved age range, ambulatory requirements, and other eligibility criteria differ between countries. In the United States, the FDA currently indicates Elevidys for ambulatory patients aged 4 years and older with a confirmed DMD mutation.
Japan, Brazil, Israel, and the Gulf countries have their own national regulatory requirements and approved indications. Therefore, approval in one country does not automatically mean that a patient is eligible for treatment in another.
Is Elevidys Approved in Europe?
No. Elevidys is not approved in the European Union.
The European Medicines Agency (EMA) reviewed Roche’s marketing authorisation application for Elevidys. On 24 July 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion, recommending refusal of the marketing authorisation. Read More: Why Elevidys Was Not Approved by the EMA?
The EMA stated that the pivotal study did not demonstrate a statistically significant improvement in the North Star Ambulatory Assessment (NSAA) after 12 months compared with placebo. The EMA also noted that the observed dystrophin expression could not be linked to an improvement in movement ability.
This means that Elevidys does not currently have EU-wide marketing authorisation.
What Does the EMA Negative Opinion Mean?
The EMA’s decision applies to the European Union regulatory process. It does not cancel Elevidys approvals granted by regulators in other countries.
Roche has stated that it intends to continue discussions with European regulators and explore a potential path toward making Elevidys available to people with DMD in the EU.
Families should therefore distinguish between:
FDA approval in the United States → Yes
Approval in several other countries → Yes
European Union/EMA approval → No, following the negative opinion
For additional information: Elevidys Frequently Asked Questions
Important: Regulatory approvals and treatment eligibility can change. Patients and families should confirm the current status and local eligibility requirements with their country’s regulatory authority and a qualified DMD specialist.
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