Drug updated on 2/6/2025
| Dosage Form | Tablet (oral; 4 mg vanzacaftor, 20 mg tezacaftor, 50 mg deutivacaftor; 10 mg vanzacaftor, 50 mg tezacaftor, 125 mg deutivacaftor) |
| Drug Class | Cystic fibrosis transmembrane conductance regulator (CFTR) potentiators |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene
Latest News
Summary
- This summary is based on the review of one randomized controlled trial(s). [1]
- In Trial VX20-121-102, the absolute change in Forced Expiratory Volume in 1 Second (FEV₁) % predicted from baseline through week 24 was 0.5 percentage points (Standard Error [SE]: 0.3) in the vanzacaftor-tezacaftor-deutivacaftor group and 0.3 percentage points (SE: 0.3) in the elexacaftor-tezacaftor-ivacaftor group, with a least squares mean (LSM) treatment difference of 0.2 percentage points (95% Confidence Interval [CI]: -0.7 to 1.1; P < 0.0001).
- In Trial VX20-121-103, the absolute change in FEV₁ % predicted was 0.2 percentage points (SE: 0.3) in the vanzacaftor-tezacaftor-deutivacaftor group and 0.0 percentage points (SE: 0.2) in the elexacaftor-tezacaftor-ivacaftor group, with an LSM treatment difference of 0.2 percentage points (95% CI: -0.5 to 0.9; P < 0.0001).
- The effectiveness of vanzacaftor-tezacaftor-deutivacaftor was non-inferior to elexacaftor-tezacaftor-ivacaftor in both trials based on absolute change in FEV₁ % predicted, with treatment differences within the non-inferiority margin.
- The incidences of common adverse events (AEs) were similar between vanzacaftor-tezacaftor-deutivacaftor and elexacaftor-tezacaftor-ivacaftor, including infective pulmonary exacerbation (28% vs. 32%), cough (23% vs. 21%), COVID-19 (22% vs. 26%), and nasopharyngitis (21% vs. 19%).
- No significant safety concerns or adverse effects unique to specific population types and subgroups were reported in the reviewed studies.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor) Prescribing Information. | 2025 | Vertex Pharmaceuticals Incorporated 50 Northern Avenue Boston, MA |
Randomized Controlled Trials
| Document Title | Sex Distribution | Year | Source |
|---|---|---|---|
| Vanzacaftor-tezacaftor-deutivacaftor versus elexacaftor-tezacaftor-ivacaftor in individuals with cystic fibrosis aged 12 years and older (SKYLINE Trials VX20-121-102 and VX20-121-103): results from two randomised, active-controlled, phase 3 trials | 971Subjects F: 46% M: 54% | 2024 | The Lancet. Respiratory Medicine |
Sex Distribution:
F:46%
M:54%
971Subjects
Year:
2024
Source:The Lancet. Respiratory Medicine