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Kalydeco Approval History

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 6 months and older who have one mutation in the CFTR gene that is responsive to ivacaftor.

Development History and FDA Approval Process for Kalydeco

DateArticle
Apr 30, 2019Approval 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, 2018Approval FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene
Aug  1, 2017Approval FDA Approves Kalydeco (ivacaftor) for People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations
May 17, 2017Approval FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis
Mar 18, 2015Approval FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 2 to 5 with CFTR Gene Mutations
Dec 29, 2014Approval FDA Approves Kalydeco (ivacaftor) for Use in People with Cystic Fibrosis Ages 6 and Older Who Have the R117H Mutation
Jan 31, 2012Approval FDA Approves Kalydeco to Treat Rare Form of Cystic Fibrosis
Dec 15, 2011FDA Grants Priority Review for Kalydeco (ivacaftor), the First Potential Medicine to Target the Underlying Cause of Cystic Fibrosis
Oct 26, 2011Vertex 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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