The Medical Letter TML n. 12 / 2024
Nr. 12 del 10/06/2024
TML n. 12 / 2024 Ritiro volontario di Relyvrio
Relyvrio, la combinazione a dose fissa di fenilbutirrato di sodio e taurursodiolo che aveva ricevuto un'approvazione accelerata da parte della US Food and Drug Administartion per il trattamento della sclerosi laterale amiotrofica (SLA) nel 2022 sulla base di uno studio di fase 2 che aveva dimostrato che il farmaco rallentava il declino funzionale1, è stato volontariamente ritirato dal mercato. Il farmaco non è mai stato commercializzato in Italia. Secondo il produttore (Amylyx), la decisione di ritirare Relyvrio si è basata sui risultati di uno studio di fase tre di 48 settimane (PHOENIX).
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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