Sanofi faces shortage of two Pompe disease drugs after FDA flags manufacturing issues

Sanofi has reported a shortage of two medicines used to treat Pompe disease. The shortage emerged after the U.S. Food and Drug Administration issued a warning about manufacturing problems at the company’s Irish production facility.

The FDA warning highlighted concerns over the facility’s ability to consistently produce the drugs to required quality standards. Sanofi is working to address the issues and restore supply.

In response, the company has notified patient advocacy groups and physicians about the limited availability, urging them to consider alternative treatment options where possible.