ORKAMBI (Vertex Pharmaceuticals Australia Pty Ltd)
Product name
ORKAMBI
Date registered
Evaluation commenced
Decision date
Approval time
229 working days (255)
Active ingredients
ivacaftor; lumacaftor
Registration type
EOI
Indication
ORKAMBI (tablets) is now also indicated for the treatment of cystic fibrosis (CF) in patients age 6 to 11 years who are homozygous for the F508del mutation in the CFTR gene.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.