Skip to Content

Elexacaftor, ivacaftor and tezacaftor Approval Status

FDA Approved: No
Generic name: elexacaftor, ivacaftor and tezacaftor
Company: Vertex Pharmaceuticals Incorporated
Treatment for: Cystic Fibrosis

Elexacaftor (VX-445), tezacaftor and ivacaftor is a triple combination regimen in development for the treatment of cystic fibrosis.

Development Status and FDA Approval Process for elexacaftor, ivacaftor and tezacaftor

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.