Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to <24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.

Key Inclusion Criteria:

• Participants From Study VX16-809-122 Part B (Study 122)

  • Completed the 24-week Treatment Period and the Safety Follow-up Visit in Study 122B

• Participants Not From Study 122

  • Subjects will be 1 to less than 2 years of age
  • Homozygous for the F508del mutation (F/F)

Key Exclusion Criteria:

• Any clinically significant laboratory abnormalities that would interfere with the study assessments or pose an undue risk for the subject
• Solid organ or hematological transplantation

Other protocol defined Inclusion/Exclusion criteria may apply.