The Medical Letter TML n. 22/2016
Nr. 22 del 15/11/2016
TML n. 22/2016 – DACLIZUMAB PER LA SCLEROSI MULTIPLA
La US Food and Drug Administration (FDA) ha approvato il daclizumab (Zinbryta-Biogen/Abbvie; farmaco approvato in Europa, ma non disponibile in commercio in Italia), un anticorpo monoclonale antagonista dei recettori dell’interleuchina- 2 (IL-2), per il trattamento degli adulti affetti da forme recidivanti di sclerosi multipla (SM). È il primo anticorpo monoclonale iniettato per via sottocutanea a essere approvato per il trattamento della SM.
Per motivi di sicurezza, il foglio illustrativo raccomanda di utilizzare il daclizumab solo per i pazienti che hanno ottenuto una risposta inadeguata a due o più degli altri farmaci per la SM; il farmaco è accessibile solo attraverso un programma di strategia di valutazione e mitigazione dei rischi (REMS). Nel 1997 la FDA aveva approvato un’altra formulazione EV del daclizumab (oggi non è più in commercio) per la prevenzione del rigetto acuto del trapianto del rene.
Questo è l'abstract dell'articolo. Per poter consultare l'intero numero o più numeri scegli il tipo di abbonamento che preferisci.
Se sei già abbonato accedi.
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