We want to assure you that we are working closely across global and local cross-functional teams to monitor the situation, manage available supply, minimise patient impact where possible, support continuity of care, and provide the most current information. At the same time, we communicate with regulatory authorities in accordance with local reporting requirements.
The reason for the delay is the issuing of an FDA Warning Letter to Sanofi’s manufacturing facility in Waterford, Ireland regarding specific quality processes for two other products not related to lysosomal storage disorder (LSD) treatments. However, actions underway at the site in response to this have contributed to intermittent supply disruptions for some products in some countries.
Despite our ongoing efforts, these intermittent supply disruptions may continue for the next few months. The impact varies by country and by product, depending on available inventory, local demand and the timing of upcoming shipments. In some countries, delays are limited; in others, intermittent or recurring supply disruptions have impacted patients or may do so as the situation evolves.
Continuity of care remains our absolute priority. We will continue to communicate as new information becomes available and work closely with healthcare partners and patient advocacy groups as we manage this situation.
Patients should speak with their treating physicians for any questions about their treatment plans.