The U.S. Food and Drug Administration has approved the use of ivacaftor (Kalydeco®) for children as young as 6 months.
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After several months of telehealth visits with my care team, I returned to the clinic for an in-person visit. Because of COVID-19, some aspects of the visit were different than before.
COVID-19 has introduced telehealth appointments to my cystic fibrosis care. I've learned that advocating for myself is even more important when my care team and I can't be in the same room.
Today, Vertex Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration has accepted its application to expand Trikafta® (elexacaftor/tezacaftor/ivacaftor) to include children ages 6-11 years old with cystic fibrosis who have at least one F508del or a mutation in the CFTR gene that is responsive based on in vitro data. The FDA has granted priority review of the application and has indicated that it will make a decision by June 8, 2021.
Quarterly visits to a CF Foundation-accredited care center are the foundation of your treatment plan. By partnering with your care team, you can also adjust your treatment plan as new therapies become available, or your needs change over time.
Vertex Pharmaceuticals Inc. has submitted three supplemental New Drug Applications to the U.S. Food and Drug Administration (FDA) to expand eligibility for Trikafta® (elexacaftor/tezacaftor/ivacaftor), Symdeko® (tezacaftor/ivacaftor and ivacaftor) and Kalydeco® (ivacaftor) to additional rare CFTR mutations.
Today, Vertex Pharmaceuticals Inc. announced positive Phase 3 clinical trial data for Trikafta® (elexacaftor/tezacaftor/ivacaftor) in children 6-11 years old with cystic fibrosis.
When it comes to my cystic fibrosis care, some might say that my situation is a bit unique. Although having not one -- but two -- CF care teams can be challenging, I strongly believe that has made me a better, smarter, and more engaged patient.
Nine cystic fibrosis care centers were awarded the 2013 - 2014 Cystic Fibrosis Quality Care Award for outstanding service to people with CF and their families at the 28th annual North American Cystic Fibrosis Conference in Atlanta.