November 20, 2025

Human medicines European public assessment report (EPAR): Kaftrio, ivacaftor,tezacaftor,elexacaftor, Date of authorisation: 21/08/2020, Revision: 31, Status: Authorised

IntelME Verdict

Clinical Breakthrough

TL;DR

Kaftrio, a medication for cystic fibrosis patients with specific gene mutations, received EU approval on 21 August 2020, showing effectiveness and tolerability in clinical studies.

Analysis

The approval of Kaftrio for cystic fibrosis patients with specific gene mutations marks a significant clinical breakthrough. Medical professionals now have an effective and well-tolerated treatment option to address the high unmet medical need in this patient population, potentially improving outcomes and quality of life.