31 May 2024 - The EMA has recommended granting a conditional marketing authorisation in the European Union for Durveqtix (fidanacogene elaparvovec) to treat severe and moderately severe haemophilia B in adults who do not have factor IX inhibitors (auto-antibodies produced by the immune system against factor IX replacement medicines) and who have no detectable antibodies to variant adeno-associated virus serotype Rh74.

The recommendation is based on the results of an on-going single-arm, open-label, Phase 3 trial in 45 adult male patients with moderately severe or severe haemophilia B who tested negative for neutralising antibody to AAVRh74var and received a single intravenous infusion of fidanacogene elaparvovec.

Read EMA press release