The Medical Letter TML n. 11/2016
Nr. 11 del 01/06/2016
TML n. 11/2016 – LUMACAFTOR/IVACAFTOR PER LA FIBROSI CISTICA
La US Food and Drug Administration (FDA) ha approvato un’associazione precostituita di lumacaftor e ivacaftor (Orkambi-Vertex negli USA; farmaco approvato in Europa, ma non disponibile in commercio in Italia) per il trattamento orale della fibrosi cistica (FC) nei pazienti di età pari o superiore ai 12 anni, omozigoti per la mutazione F508del. Negli Stati Uniti, il 50% circa dei pazienti affetti da FC è omozigote per la mutazione F508del (detta anche Phe508del). Si tratta della prima indicazione approvata per il lumacaftor; l’ivacaftor è disponibile da solo come Kalydeco (Vertex Pharmaceuticals) per il trattamento della FC nei pazienti di età pari o superiore ai 2 anni con altre mutazioni (1). Orkambi è il primo farmaco a essere approvato negli Stati Uniti per il trattamento dei pazienti con mutazione F508del.
Questo è l'abstract dell'articolo. Per poter consultare l'intero numero o più numeri scegli il tipo di abbonamento che preferisci.
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