← All approvals · Kidney, liver & lung · 2024
Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor)
The FDA approved Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor) on December 20, 2024 For the treatment of cystic fibrosis (CF) in patients 6 years of age and older.
- Brand name
- Alyftrek
- Generic name
- vanzacaftor, tezacaftor, and deutivacaftor
- FDA approval date
- December 20, 2024
- Approved use (FDA wording)
- For the treatment of cystic fibrosis (CF) in patients 6 years of age and older
- Company
- Vertex Pharms Inc.
- Application
- NDA218730
- Dosage form / route
- TABLET · ORAL
- Drug class (EPC)
- Cystic Fibrosis Transmembrane Conductance Regulator Potentiator [EPC]
- Boxed warning on label
- Yes (see the FDA label)
- Category on this site
- Kidney, liver & lung
Indications and usage, from the FDA label
ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator ( CFTR ) gene that is either responsive based on clinical and/or in vitro data (see Table 5 ) or results in production of CFTR protein [see Clinical Pharmacology (12.1) ]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein. ALYFTREK is a combinat…