KALYDECO (Vertex Pharmaceuticals Australia Pty Ltd)
Product name
KALYDECO
Date registered
Evaluation commenced
Decision date
Approval time
143 (175 working days)
Active ingredients
ivacaftor
Registration type
EOI
Indication
KALYDECO is indicated for the treatment of cystic fibrosis (CF) in patients aged 1 month and older who have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, and Section 5.1 PHARMACODYNAMIC PROPERTIES).