← Back to The Docket APR 1 2026
APPROVED · 181 DAYS AGO
— Alyftrek, Trikafta (vanzacaftor/tezacaftor/deutivacaftor, elexacaftor/tezacaftor/ivacaftor)
$VRTX
for cystic fibrosis
NDA
FDA approved expanded use of Alyftrek and Trikafta for cystic fibrosis treatment, increasing availability to ~95% of patients.
About
Cystic fibrosis is a genetic disorder where thick mucus builds up in the lungs and other organs, leading to frequent bacterial infections and progressive breathing difficulties. Alyftrek and Trikafta are combination drugs that improve the function of the defective protein in cystic fibrosis cells, helping clear mucus from the airways. This may reduce lung infections and ease breathing, addressing the underlying cause of the disease for most people with CF.