TRIKAFTA (Vertex Pharmaceuticals Australia Pty Ltd)
Product name
TRIKAFTA
Date registered
Evaluation commenced
Decision date
Approval time
218 (255 working days)
Active ingredients
elexacaftor; ivacaftor; tezacaftor
Registration type
NCE/NBE
Indication
TRIKAFTA (tablet) is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.