Alyftrek is a once-daily triple-combination CFTR modulator (vanzacaftor/tezacaftor/deutivacaftor) for cystic fibrosis in patients aged 6 years and older with eligible CFTR variants. It was FDA approved in December 2024 and later received an FDA label expansion in April 2026 to include variants that result in production of CFTR protein. The therapy aims to increase the quantity and function of CFTR protein at the cell surface.
- Drug Class
- Triple-combination CFTR modulator
- Approval Status
-
FDA approved (December 20, 2024); indication expanded by FDA on April 1, 2026
- Mechanism of Action
- Vanzacaftor and tezacaftor facilitate CFTR processing/trafficking to the cell surface, while deutivacaftor potentiates CFTR channel gating, increasing CFTR quantity and function
Indications
- \Cystic fibrosis in adults and pediatric patients aged 6 years and older with at least one responsive CFTR variant or a variant resulting in CFTR protein production\