TRIKAFTA (Vertex Pharmaceuticals Australia Pty Ltd)
Product name
TRIKAFTA
Date registered
Evaluation commenced
Decision date
Approval time
187 (255 working days)
Active ingredients
elexacaftor, ivacaftor, tezacaftor
Registration type
EOI
Indication
TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in patients aged 2 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.
This webpage on the TGA website was printed on 12 Sep 2024. Printed content may be out of date. For up-to-date information, always refer to the digital version: https://www.tga.gov.au/resources/prescription-medicines-registrations/trikafta-vertex-pharmaceuticals-australia-pty-ltd-1