It has been confirmed that there will be intermittent shortages of these drugs in many countries, but when potential shortages will start and how long they will last is currently unknown. The impact on each country will differ depending on the stock currently available and the number of patients in that country. Sanofi UK is taking steps to determine current stock levels in the UK to assess the potential impact here.
When the CEO of Pompe Support Network, who is also on the International Pompe Association board, participated in a meeting with Sanofi’s global representative, they confirmed that there is sufficient enzyme available and that there is no quality issue with the compound. The issue is at the final fill-and-finish stage. The FDA inspected Genzyme Ireland Limited in Waterford where the drugs are made and packaged, in January 2026, and issued a form listing core findings, followed by a Warning Letter in June. The FDA findings had to do with other drugs manufactured at the same site, but the actions taken to address those problems are also affecting the Myozyme and Nexviadyme supply.
Sanofi assured PSN they are working at pace to resolve the issue and confirmed that they will provide regular updates on the process. PSN will post more updates as things develop.
Sanofi is also in the process of informing UK physicians about the situation.
Sanofi Drug Supply Issue
Posted On: 11/08/2026 Recently Posted!
Announcements from some international sources have revealed that there is currently a supply issue with two Sanofi Pompe drugs, Myozyme and Nexviadyme. Pompe Support Network has been investigating whether the issue might impact the UK. PSN had a meeting with Sanofi UK representatives to find out more.