SYMDEKO (Vertex Pharmaceuticals Australia Pty Ltd)
Product name
SYMDEKO
Date registered
Evaluation commenced
Decision date
Approval time
228 working days (255)
Active ingredients
ivacaftor; tezacaftor
Registration type
NCE/NBE
Indication
Symdeko (film-coated tablets) is indicated for the treatment of patients with cystic fibrosis (CF) aged 12 years and older who are homozygous for the F508del mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.