Last update on 16 October 2026
Supply interruptions continue to affect Sanofi’s enzyme replacement therapies for Pompe, ASMD, Fabry and Gaucher in some countries. Sanofi has, however, made important progress toward restoring consistent supply of its enzyme replacement therapies. Imported product has been shipped to help meet patient needs in many countries that have experienced treatment interruptions. In addition, the European Medicines Agency and the U.S. Food and Drug Administration have approved a new manufacturing process intended to expand production capacity. This is an important step forward; while these approvals will allow product from this manufacturing process to begin to reach the market, realization of the full effect will take time.
While supply conditions have improved, we cannot yet provide a single global date for full restoration because circumstances vary by product and country, and unexpected delays may still occur. We will continue to keep patients, healthcare providers and regulatory authorities informed through country-specific updates as supply availability and local conditions evolve. Every batch released continues to meet all established requirements for identity, strength, quality and purity.
Continuity of care remains our highest priority. Healthcare providers with questions about product availability should contact their local Sanofi representative. Patients or family members affected by a delay are encouraged to contact their doctor or healthcare team for guidance based on their individual medical needs.
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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.