August 7, 2026
Pompe Alliance, Marshall’s Mountain, Grant’s Giants, Pompe Warrior Foundation, Ryan Colburn of the Pompe Community, and the AMDA are working together to help patients obtain clear and timely information regarding reports of NexviazymeA newer enzyme replacement therapy designed to improve delivery of the enzyme to muscle cells. shipment and release delays.
At this time, the delays being reported to our organizations involve some shipments of Nexviazyme. We have not received confirmation that LumizymeA form of enzyme replacement therapy used to treat Pompe disease by providing a lab-made version of the GAA enzyme. is currently affected, but patients using either treatment may wish to verify their upcoming shipment.
This appears to be a product-release and distribution timing issue — not evidence of a safety or quality problem with medication that has already been released. Patients should not panic or make treatment changes without speaking with their prescribing medical team.
In June 2026, the FDA issued a warning letter following a January inspection of a Sanofi facility in Waterford, Ireland. Sanofi has publicly stated that products released from the facility meet established quality and safety specifications. The FDA warning letter does not specifically identify Nexviazyme or Lumizyme as affected products, and we cannot independently confirm the precise cause of every current shipment delay.
What patients should do
- Contact Sanofi directly. Reach out to your CareConnectPSS Case Manager, Patient Education Liaison, or other established Sanofi contact and ask whether your next ERT shipment may be delayed.
If you do not know your contact, call:
Sanofi CareConnectPSS: 1-800-745-4447, Option 3
A representative can connect you with the appropriate person. - Confirm your communication preferences.
Ask whether your consent forms are current and confirm that you are enrolled to receive notifications by both text message and email. Updating these preferences should be a quick process. - Contact your medical and infusionA method of delivering medication through an IV. teams.
Once you receive confirmation about your shipment, notify the physician who prescribes your ERT, your infusion provider, and your specialty pharmacy. Your medical team — not the patient-support representative — should advise you about any treatment or scheduling decisions.
Do not skip, delay, substitute, or change an infusion plan without medical guidance.
Sanofi is also communicating with physicians, infusion providers, distributors, and specialty pharmacies. However, contacting your assigned Sanofi representative directly may be the quickest way to obtain information specific to your shipment.
We understand how concerning any uncertainty involving a lifelong treatment can be. Our organizations remain committed to patient empowerment, transparent communication, and helping every Pompe patient receive accurate information and uninterrupted care.
Jointly issued by:
Pompe Alliance
Marshall’s Mountain
Grant’s Giants
Pompe Warrior Foundation
Ryan Colburn, Pompe Community
The Acid Maltase Deficiency Association (AMDA)