Treats cystic fibrosis (CF). NDA 218730, held by Vertex Pharms Inc. Deutivacaftor; Tezacaftor; Vanzacaftor Calcium.
As of Nov 13, 2026, NDA 218730 (Alyftrek), held by Vertex Pharms Inc, was first approved by FDA on Dec 20, 2024, with 3 approved supplements and 0 published complete response letters.
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. 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.
| Mar 27, 2026 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2024 | Original applicationNew molecular entity · Priority review | Approved |
| Alyftrek50MG;20MG;EQ 4MG BASE · tablet;oral | Deutivacaftor; Tezacaftor; Vanzacaftor Calcium | RxReference drug |
| Alyftrek125MG;50MG;EQ 10MG BASE · tablet;oral | Deutivacaftor; Tezacaftor; Vanzacaftor Calcium | RxReference drug |
| Mar 27, 2026 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Mar 17, 2026 | Supplement 3Labeling | Approved | |
| Sep 25, 2025 | Supplement 2Labeling · Standard review | Approved | |
| Dec 20, 2024 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
