FOS has been conducted worldwide for more than 20 years. The data collected over this time has provided detailed information on the safe and effective use of Replagal, and the registry has made important contributions to our better understanding of Fabry disease. In total, 58 manuscripts have been published in peer reviewed journals and many more abstracts and posters have been presented in scientific meetings, creating a benchmark for Fabry registries.
FOS was originally set up as a post-authorization commitment to provide additional data for Replagal use. Over time, the EMA has regularly reviewed the collected data and since 2015 considers the regulatory commitment as fulfilled.
All of this has been possible because of your continuous support, the active engagement of the Fabry patient community, contributing to the creation and upkeep of a large database with a high scientific value. Within the 20 years of data collection and analyses FOS has been able to address a number of important scientific questions about Fabry disease and its management.
Therefore, we would like to inform you, that after careful consideration, the difficult decision has been taken to close the FOS registry.
As the first step of the closing process, we have announced the enrolment stop for July 31st, 2021, and the timing for final study visits has now also been confirmed: the last patient visit took place on September 30th, 2021.
As FOS is an observational study, patient care will continue as usual. Therefore, there will be no change in treatment or follow up routine for any of the patients participating in FOS as a consequence of FOS closure. The only difference will be that after this date, and with ending their participation in the FOS study, no further data of the patients who have participated in FOS will be entered into the FOS database.
We know that this is a significant change that may come unexpected. Therefore, it is important for us to assure you that it does not affect our overall commitment to Fabry and the LSD space, and Takeda remains committed to the Fabry and LSD communities and supporting patients with current and future innovative treatments.
We are grateful for the immense resource that FOS has been for us and the Fabry community for more than 20 years: over 5000 patients have provided their data over time, and in this way contributed to a greater understanding of Fabry disease. Because of these willing participants, many more Fabry patients have benefited from better management of their condition.
We would like to take this opportunity to thank you and all Fabry patients once again for your commitment over the years, which has allowed us to reach this important milestone.
