ALYFTREK (Vertex Pharmaceuticals Australia Pty Ltd)
Product name
ALYFTREK
Date registered
Evaluation commenced
Decision date
Approval time
212 (255 working days)
Active ingredients
deutivacaftor, tezacaftor, vanzacaftor calcium
Registration type
New combination
Indication
Alyftrek is indicated for the treatment of those who meet the diagnostic criteria for cystic fibrosis (CF) in people aged 6 years and older who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive based on clinical or in vitro evidence (see section 5.1 PHARMACODYNAMIC PROPERTIES, Table 4).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.