Trial Profile
A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 04 Nov 2021
Price :
$35
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At a glance
- Drugs Ivacaftor/tezacaftor (Primary) ; Ivacaftor
- Indications Cystic fibrosis
- Focus Registrational; Therapeutic Use
- Sponsors Vertex Pharmaceuticals
- 27 Nov 2020 According to the Vertex Pharmaceuticals media release, European Commission has granted approval of the label extension for SYMKEVI (tezacaftor/ivacaftor) with KALYDECO (ivacaftor), to include the treatment of cystic fibrosis (CF) in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene.
- 21 Jun 2019 According to a Vertex Pharmaceuticals media release, An additional dosage strength of SYMDEKO tablets is now available (tezacaftor 50 mg/ivacaftor 75 mg and ivacaftor 75 mg) in connection with this approval.
- 21 Jun 2019 According to a Vertex Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) approved SYMDEKO (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6 through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to SYMDEKO.