The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
ORKAMBI (Vertex Pharmaceuticals Australia Pty Ltd)
Product name
ORKAMBI
Date registered
Evaluation commenced
Decision date
Approval time
221 working days (255)
Active ingredients
lumacaftor/ivacaftor
Registration type
EOI
Indication
ORKAMBI (granules) is now also indicated for the treatment of cystic fibrosis (CF) in patients age 2 to 5 years who are homozygous for the F508del mutation in the CFTR gene.