05. Can I get Filsuvez® in other countries?

Filsuvez® received a marketing authorisation from the MHRA, valid in England, Scotland and Wales, in September 2022. The European Medicines Authority (EMA) authorised its use throughout the EU and in Northern Ireland in June 2022.  Application to the Food and Drug Administration (FDA) for marketing authorisation in the US was rejected in February 2022 as needing more evidence that it was effective in EB.