Last update on 11 September 2026
Supply interruptions continue to affect Sanofi’s enzyme replacement therapies for Pompe, ASMD, Fabry and Gaucher in some countries. The timing and extent of these interruptions vary by product and country, which is due to differences in the inventory volume across the products, local patient demand, shipment and release scheduling, and the regulatory steps required before product can be distributed. Some countries currently have sufficient supply or are experiencing only limited delays. In others, patients have already experienced intermittent or recurring interruptions, and further interruptions may occur as supply conditions remain fluid.
We are working closely with local teams to minimize disruption for patients currently on treatment, ensure access for those with urgent medical need, and work within each country’s regulatory framework. Specifically, we are closely monitoring inventory and demand by country, accelerating shipment timing and logistics when product can be released earlier and working with local health authorities on temporary import or distribution arrangements. The availability of these measures varies by country and product and is subject to applicable regulatory requirements.
The situation remains dynamic, and we are working urgently to restore consistent supply. However, given the differences by product and country and the ongoing potential for unexpected release delays, we cannot yet provide a single global date for full restoration. We will continue to provide country-specific updates to patients, healthcare providers and regulatory authorities as supply availability, demand, mitigation measures and regulatory approvals evolve. Every batch released continues to meet all established requirements for identity, strength, quality and purity.
Continuity of care remains our highest priority. If you are a healthcare provider and have concerns or questions about product availability, please reach out to your local Sanofi representative. If you are a patient or a family member of a patient and you are impacted by these delays, please reach out to your doctor, or healthcare team, who can provide guidance based on your individual medical needs.
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Update on 17 August 2026
Sanofi's Waterford, Ireland manufacturing facility received an FDA Warning Letter on June 23, 2026. Actions Sanofi is taking in response have contributed to shipment delays for several products in some markets. Every batch released from Waterford continues to meet all established requirements including identity, strength, quality, and purity.
The impact varies by country and by product, depending on available inventory, local demand and the timing of upcoming shipments. In some markets, delays are limited; in others, intermittent or recurring supply interruptions have reached patients or may do so as the situation evolves.
As we work to resolve the delays, we are coordinating with country affiliates to manage available supply, minimize patient impact, and support continuity of care wherever possible. At the same time, we are communicating with regulatory authorities in accordance with local reporting requirements. We will continue to provide updates as new information becomes available.
Healthcare providers should reach out to their Sanofi representative if they have any questions about the availability of affected products.
Patients may have questions or concerns about what this situation could mean for their treatment. Patients should speak directly with their treating healthcare professional, who can provide guidance based on their individual medical needs.