Vertex to file for approval of triple CFTR modulator regimen by mid-2024

6 February 2024

US biopharma Vertex Pharmaceuticals (Nasdaq: VRTX) has announced positive results from its once-daily vanzacaftor/tezacaftor/deutivacaftor program, the most comprehensive Phase III pivotal program ever conducted by the company for cystic fibrosis (CF).

The program included two randomized, double-blind, active-controlled, 52-week trials, SKYLINE 102 and SKYLINE 103, evaluating the efficacy of the regimen in people with CF aged 12 years and older who have at least one F508del mutation or a mutation responsive to triple combination CFTR modulators (CFTRm), compared to Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor).

"Raising the very high bar set by Trikafta"

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