is now registered by the TGA for Australians with cystic fibrosis aged 6 years and older with at least one responsive CFTR mutation–
Approximately 3,200 Australians may now be eligible for this next-in-class treatment for cystic
fibrosis1 –
SYDNEY, 20 November 2025 – Vertex Pharmaceuticals today announced that the Therapeutic Goods Administration (TGA) has approved the use of ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) for the treatment of people aged 6 years and older who meet the diagnostic criteria for cystic fibrosis (CF) and who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive based on clinical or in vitro evidence2.
ALYFTREK is the latest treatment option for CF and 5th CFTR modulator to be approved in Australia; a once daily, triple combination therapy, targeting the underlying cause of the disease by improving CFTR function at and below the cell surface3.
"For more than 20 years, Vertex has worked alongside the CF community to develop therapies that target the cause of this disease," said Dr. Kasia Siwek, Medical Director, Vertex Pharmaceuticals Australia and New Zealand. "With this TGA registration, more children and adults living with CF in Australia are one step closer to accessing this next in class treatment option for cystic fibrosis. It is a testament to our commitment to serially innovate and continue to improve the lives of people living with CF."
The TGA registration of ALYFTREK is based on global clinical trials that assessed its safety and efficacy in people with CF aged 6 years and over, supported by real world evidence and in vitro data. Detailed information on side effects, precautions, and dosing is available in the Consumer Medicine Information (CMI).
Patients and caregivers should speak with their treating healthcare professional to understand if ALYFTREK may be suitable for them.
