Is Deutivacaftor + Tezacaftor + Vanzacaftor approved by the US FDA?

Drugs@FDA lists 1 application product line for Deutivacaftor + Tezacaftor + Vanzacaftor, including ALYFTREK (Prescription).

Is Deutivacaftor + Tezacaftor + Vanzacaftor authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Deutivacaftor + Tezacaftor + Vanzacaftor: Alyftrek.

Active substances

Deutivacaftor + Tezacaftor + Vanzacaftor

US FDA 1
EMA 1
Health Canada 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ALYFTREK	50MG;20MG;EQ 4MG BASE; 125MG;50MG;EQ 10MG BASE	tablet · oral	VERTEX PHARMS INC	Prescription	20 Dec 2024

EMA European Union — centrally authorised medicines

Alyftrek Vertex Pharmaceuticals (Ireland) Limited · Authorised · authorised 30 Jun 2025 · ATC R07AX33

Therapeutic indication (EMA)

Alyftrek tablets are indicated for the treatment of cystic fibrosis (CF) in people aged 6 years and older who have at least one non-Class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (see sections 4.2 and 5.1).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALYFTREK	02559676	4 MG; 50 MG; 20 MG	TABLET · ORAL	VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
ALYFTREK	02559684	50 MG; 10 MG; 125 MG	TABLET · ORAL	VERTEX PHARMACEUTICALS (CANADA) INCORPORATED

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.