The Medical Letter TML n. 24/2015
Nr. 24 del 15/12/2015
TML n. 24/2015 – UNA PROTEINA DI FUSIONE DEL FATTORE VIII RICOMBINANTE PER L’EMOFILIA A
La US Food and Drug Administration (FDA) ha approvato Eloctate (Biogen in USA; in Europa il farmaco – con il nome commerciale Elocta – ha ricevuto il parere positivo del CHMP in data 24/09/2015; non disponibile in commercio in Italia), una proteina di fusione del fattore VIII ricombinante con dominio Fc dall’emivita prolungata, per l’uso negli adulti e nei bambini affetti da emofilia A. Eloctate è indicato per il controllo e la prevenzione degli episodi emorragici, la gestione perioperatoria e la profilassi di routine per prevenire o ridurre la frequenza degli episodi emorragici. È la prima proteina di fusione del fattore VIII ricombinante con dominio Fc ad essere approvata per l’emofilia A.
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