Patients with Pompe disease in the United States and Europe are reporting delayed shipments of the enzyme infusions that keep the condition from progressing, and the manufacturer has confirmed that the supply of two products is constrained.
Sanofi is facing shortfalls of Myozyme and Nexviazyme, according to reporting by STAT, which described a bottleneck in the final manufacturing phase along with quality control problems at the company's plant in Waterford, Ireland. The site handles batch release, the final quality assurance step before a manufactured lot can be shipped.
