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.
As an adult with cystic fibrosis, becoming a foster parent seemed like a great option for me and my husband to build our family. Although fostering three kids for our first placement certainly came with its fair share of challenges, we wouldn't change it for the world.
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.
My husband and I had always said that we would either have no kids, or we would have two. But, when our first child was diagnosed with cystic fibrosis, we were suddenly faced with a difficult decision.
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.
Women with cystic fibrosis can safely breastfeed without compromising their baby's health. However, there are still factors related to your own health that you will need to consider before you decide whether breastfeeding is right for you.