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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More women with cystic fibrosis are reaching reproductive age, becoming pregnant, and delivering babies. Nutrition before and during pregnancy is essential for all women.
Does Trikafta® increase the chance of pregnancy for women with cystic fibrosis? Can men regain their fertility on modulators? I recently had a candid chat with the chair of the Women's Health Research Working Group to find out the answers to these and other questions about reproductive health.
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.
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.
Today, Vertex Pharmaceuticals Inc. announced positive Phase 3 study results for Trikafta® (elexacaftor/tezacaftor/ivacaftor) for people with cystic fibrosis ages 12 years and older who have one copy of the F508del mutation and one gating or residual function mutation.
Pregnant women with cystic fibrosis will need to be more closely monitored than the average pregnant woman. Learn how you can partner with your CF care team and obstetric team to effectively manage your pregnancy.
At the age of 30, I faced the difficult reality of a conclusive cystic fibrosis diagnosis and the CF-related infertility that came with it. Although I experienced a lot of guilt as my wife and I built our family and I hated seeing her suffer because of my disease, our journey with in-vitro fertilization (IVF) proves that you can be a father despite living with CF.