KALYDECO (Vertex Pharmaceuticals Australia Pty Ltd)
Product name
KALYDECO
Date registered
Evaluation commenced
Decision date
Approval time
212 working days (255)
Active ingredients
ivacaftor
Registration type
EOI
Indication
KALYDECO (film-coated tablets, granules) is now also indicated for the treatment of cystic fibrosis (CF) in patients aged 12 months and older who have one of the following gating (class III) mutations in the CFTR gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, and Section 5.1 PHARMACODYNAMIC PROPERTIES).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.