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Recently, the U.S. Food and Drug Administration (FDA) has granted efanesoctocog alfa "fast-track eligibility" (FTD) for the treatment of haemophilia Type A.
Efanesoctocog alfa was awarded the "Orphan Drug Title" by the FDA in August 2017 and the European Commission in June 2019.
Efanesoctocog alfa is a new type 2 factor replacement therapy for haemophilia A.
half-life of conventional VIII factor therapy is limited by the von Willebrand factor (VWF) companion effect, which is thought to limit the duration of the VIII factor's stay in the body.
Efanesoctocog alfa adds a regional von Willebrand factor and XTEN®peptide to its innovative Fc fusion technology to extend its half-life.
Efanesoctocog alfa has the potential to provide near-normal blood protection for most of the week, while an extended half-life may reduce the frequency of preventive treatment to once a week.
currently, phase III XTEND-1 studies are evaluating the safety and effectiveness of Efanesoctocog alfa treatment ≥12-year-old patients with haemophilia A (n s 150).
prevention group received 50 IU/kg doses of efanesoctocog alfa preventive treatment per week for 52 weeks, while patients in the control group received BIVV001 (50 IU / kg) on demand for 26 weeks and then switched to efanesoctocog alfa for 26 weeks per week.
