Sanofi reports shortages of Myozyme and Nexviazyme for Pompe disease after FDA manufacturing warning

Sanofi has warned that supplies of two medicines used to treat Pompe disease are running low. The company notified patient groups and physicians in the United States and Europe that the shortage affects both Myozyme, an older standard of care, and Nexviazyme, a newer enzyme replacement therapy.

Myozyme and Nexviazyme are critical for managing the rare, progressive disorder, which requires regular infusions to maintain muscle function. Patients rely on consistent dosing to avoid disease progression and complications.

The shortage follows an FDA warning to Sanofi over manufacturing problems at its Waterford, Ireland facility. The plant, responsible for the final batch release step, is experiencing a bottleneck and quality‑control issues that have delayed the certification of new product batches.

Sanofi has urged clinicians to monitor inventory closely and consider dose adjustments where possible, while patient advocacy groups are urging regulators to expedite solutions to the supply gap.