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Fibrillazione atriale e TEV: da oggi l’anticoagulante orale edoxaban prescrivibile anche in Italia

Roma 9 settembre- Dopo Giappone, Corea del Sud, Stati Uniti, Germania, Svizzera e Regno Unito, l'anticoagulante orale in monosomministrazione giornaliera edoxaban (Lixiana®) di Daiichi Sanyo, da oggi sarà prescrivibile anche in Italia in fascia rimborsabile, a seguito della pubblicazione in Gazzetta Ufficiale n. 198 del 25 Agosto 2016 della Determina 1105/2016 che classifica Lixiana in classe A.  

Il farmaco, che inibisce in modo specifico, reversibile e diretto il fattore Xa, ha ottenuto il regime di rimborsabilità per la prevenzione dell'ictus e dell'embolia sistemica (ES) in pazienti adulti con fibrillazione atriale non valvolare (FANV), per il trattamento della trombosi venosa profonda (TVP) e dell'embolia polmonare (EP) e per la prevenzione delle loro recidive. La dose raccomandata di edoxaban è di 60 mg in monosomministrazione giornaliera, con dose ridotta a 30 mg in pazienti con insufficienza renale moderata o severa (clearance della creatinina 30-50 mL/min), peso corporeo uguale o inferiore a 60 kg, o uso concomitante di inibitori della glicoproteina P (ciclosporina, dronedarone, eritromicina, ketoconazolo).  

"Siamo molto orgogliosi di annunciare che a partire da oggi sarà disponibile una nuova opzione terapeutica per prevenire efficacemente gli ictus nei pazienti affetti da fibrillazione atriale non valvolare e per il trattamento della trombosi venosa profonda. Edoxaban in monosomministrazione giornaliera offre, infatti, una combinazione estremamente valida di sicurezza, efficacia e facilità di somministrazione, persino per i pazienti più fragili, e può inoltre contare su una riduzione significativa dei sanguinamenti rispetto al trattamento a base di warfarin. -  dichiara Massimo Grandi, Country Manager Daiichi Sankyo Italia - Questo innovativo anticoagulante orale è frutto degli ingenti investimenti che da sempre Daiichi Sankyo riserva alla ricerca e sviluppo in ambito cardiovascolare, e il suo ingresso in Italia conferma ancora una volta l'impegno profuso dall'azienda a rispondere ai bisogni non ancora soddisfatti dei pazienti di tutto il mondo".   Il piano terapeutico integrale di edoxaban è consultabile sul portale AIFA nella sezione "Registri farmaci sottoposti a monitoraggio"