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FDA Broadens CFTR Therapy Eligibility

The FDA expanded use of CFTR modulators to include more CF gene variants, increasing treatment eligibility across a wider US patient population.

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The FDA has expanded the eligibility of cystic fibrosis modulators vanzacaftor/tezacaftor/ivacaftor (ALYFTREK) and elexacaftor/tezacaftor/ivacaftor (TRIKAFTA) to about 95% of cystic fibrosis patients in the US. These therapies are now available for patients aged 6 and older for ALYFTREK and 2 and older for TRIKAFTA, based on specific CFTR gene variants. This expansion is expected to benefit an additional 800 patients, although liver function monitoring and awareness of potential adverse effects are critical for safe use.

Original Source(s)

FDA Broadens CFTR Therapy Eligibility

  • by Kathryn Wighton

  • April 1, 2026

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