EMA has recommended granting a conditional marketing authorisation in the European Union (EU) 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 (AAVRh74var).
Haemophilia B is a rare inherited bleeding disorder. The condition is caused by the lack of coagulation factor IX, a protein needed to produce blood clots to stop bleeding and seal wounds. Without that protein, patients with haemophilia B bruise easily and bleed more frequently and for longer periods of time. It can lead to serious complications, such as bleeding in joints, muscles or internal organs, including the brain…
