As you may already be aware, the FDA has raised concerns following a review of Sanofi’s manufacturing site in Waterford, Ireland, where Fabrazyme is produced.
Sanofi has told us that these concerns relate to manufacturing processes, not to the medicine itself. They have also confirmed that Fabrazyme already in circulation is safe to use.
We now understand that there will be disruption to future supplies of Fabrazyme. A delivery is expected in September, but this has not yet been confirmed and until it is received, the wider and longer-term impact remains unclear; as future deliveries are also uncertain, further disruption to supply is likely.
Clinical centres are continuing to review the situation and are checking available stock, including stock held by centres, homecare pharmacies and in people’s homes. While this review is taking place, NHS England has asked for home deliveries of Fabrazyme to be temporarily paused so that a clear picture of available stock can be established. This is a precautionary measure to help ensure that existing supplies can be managed as fairly and safely as possible while the wider impact on supply is assessed.
If your or your child’s treatment is confirmed to go ahead and you do not have medicine available at home, your clinical team or homecare provider will contact you to explain arrangements.
We understand that uncertainty about treatment can be unsettling.
Clinical teams are planning carefully to reduce the impact on the Fabry community as far as possible and to help make sure that available treatment is managed safely and according to clinical need.
Because supply will be disrupted, some infusions may need to be delayed, spaced further apart or temporarily paused. In some cases, people may be offered a different treatment option. Your clinical team or homecare company will contact you if any change is needed to your usual treatment schedule and future deliveries.
We will continue to monitor the supply position closely and will share further updates as soon as we have more information.
If you have questions about your own treatment or if you notice a significant change in your symptoms, please contact your consultant or metabolic team using your usual contact details.
