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Trikafta FDA Approval History

FDA Approved: Yes (First approved October 21, 2019)
Brand name: Trikafta
Generic name: elexacaftor/tezacaftor/ivacaftor and ivacaftor
Dosage form: Tablets
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is a triple combination regimen for the treatment of cystic fibrosis (CF) in patients ages 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Development Timeline for Trikafta

DateArticle
Dec 21, 2020Approval  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
Oct 21, 2019Approval  FDA Approves Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for Cystic Fibrosis Patients Ages 12 and Older Who Have at Least One F508del Mutation
Aug 20, 2019FDA Accepts New Drug Application for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Combination Treatment
Jul 22, 2019Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
May 30, 2019Vertex Selects Triple Combination Regimen of VX-445, Tezacaftor and Ivacaftor to Submit for Global Regulatory Approvals in Cystic Fibrosis

Further information

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