Sanofi Pompe Drug Shortages Follow FDA Warning
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- Sanofi alerted patient groups and physicians in the U.S. and Europe that supplies of Myozyme and Nexviazyme, two medicines used to treat Pompe disease, are dwindling due to a bottleneck in the final manufacturing phase and quality control issues at its Waterford, Ireland plant.
- The shortage emerged shortly after the FDA warned Sanofi over manufacturing issues at the Irish facility where both drugs are made.
- Myozyme is described in the alert as an older standard of care for Pompe disease, while Nexviazyme is a newer treatment — both now constrained by problems at the same site.
- Sanofi's Waterford plant handles "batch release," the final quality assurance and regulatory step in which a manufactured batch of medicine is formally certified and cleared for distribution to patients.
Why it matters: Both Pompe treatments depend on Sanofi's Waterford, Ireland plant for final batch release, so a single facility's bottleneck and quality control problems now threaten the simultaneous supply of the older standard of care (Myozyme) and the newer alternative (Nexviazyme) for patients in the U.S. and Europe — and the disruption surfaced right after the FDA flagged the site.
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