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Vertex Announces US FDA Approval for Label Extensions of ALYFTREK® and TRIKAFTA®, Expanding Availability of These Medicines to ~95% of All People With CF in the United States

VRTX
  • The FDA approved expanded use of ALYFTREK for patients ages 6+ & TRIKAFTA for patients ages 2+ with cystic fibrosis variants that produce CFTR protein or show responsiveness in clinical/in vitro data.
  • Approximately 800 additional people in the US are now eligible for CFTR modulator therapy, bringing the total eligible population to roughly 95% of all CF patients in the US.
  • Label expansion is supported by data from 564 variants responsive to ALYFTREK & 521 variants responsive to TRIKAFTA.
  • Both medicines carry a boxed warning for drug-induced liver injury & liver failure, requiring liver function test monitoring prior to treatment, monthly for the first 6 months, every 3 months for the next 12 months, then annually.
  • ALYFTREK & TRIKAFTA are contraindicated in patients with severe hepatic impairment (Child-Pugh Class C) & not recommended for those with moderate impairment (Child-Pugh Class B).
  • Warnings include hypersensitivity reactions such as anaphylaxis, intracranial hypertension, neuropsychiatric events including suicidal thoughts, & non-congenital cataracts in pediatric patients treated with TRIKAFTA.
  • Concomitant use with strong CYP3A inducers is not recommended due to reduced drug exposure, while use with strong/moderate CYP3A inhibitors requires dose reduction.
  • Safety data for ALYFTREK is not available for patients who previously discontinued ELX, TEZ, or IVA-containing drugs due to adverse reactions.
  • ALYFTREK is not recommended for patients under age 6, & TRIKAFTA is not recommended for patients under age 2.
  • Vertex Pharmaceuticals announced this expansion today to treat the underlying cause of cystic fibrosis across a broader range of genetic variants.