Kalydeco FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
FDA Approved: Yes (First approved January 31, 2012)
Brand name: Kalydeco
Generic name: ivacaftor
Dosage form: Tablets and Oral Granules
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis
Kalydeco (ivacaftor) is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients ages 4 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor.
Development timeline for Kalydeco
| Date | Article |
|---|
| Dec 21, 2020 | Approval Vertex Announces FDA Approvals of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for Use in People With CF With Certain Rare Mutations |
| Sep 25, 2020 | Approval FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age |
| Apr 30, 2019 | Approval FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age |
| Aug 15, 2018 | Approval FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene |
| Aug 1, 2017 | Approval FDA Approves Kalydeco (ivacaftor) for People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations |
| May 17, 2017 | Approval FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis |
| Mar 18, 2015 | Approval FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations |
| Dec 29, 2014 | Approval FDA Approves Kalydeco (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation |
| Jan 31, 2012 | Approval FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis |
| Dec 15, 2011 | FDA Grants Priority Review for Kalydeco (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis |
| Oct 26, 2011 | Vertex Submits Application for Priority Review and Approval of Kalydeco (VX-770, ivacaftor) in the U.S. as First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis |
Further information
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