19/11/2025
Alyftrek has been approved for use in Australia by The Therapeutic Goods Administration (TGA).
This positive news brings us one step closer to the treatment listed on the Pharmaceutical Benefits Scheme (PBS).
Access to treatments like Alyfrek is important because while many people are now taking other CFTR modulators, others are ineligible, not responsive to existing options, or have had to stop due to adverse side effects.
We’re proud to share an important milestone for Australians living with cystic fibrosis. The Therapeutic Goods Administration (TGA) has officially approved Alyftrek for use in Australia.
This follows the recent positive recommendation from the PBAC and brings us closer to Alyftrek being listed on the PBS and accessible to everyone who could benefit.
Alyftrek is a next-generation, once-daily CFTR modulator that targets the underlying cause of CF. It is registered for the treatment of 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.
The registration confirms that eligibility is not limited to people who do not respond or have discontinued Trikafta. For those Australians with a responsive mutation this provides a further treatment option and the potential to benefit from this next-generation triple therapy.
This progress reflects strong, united advocacy led by Cystic Fibrosis Australia together with our state and territory members, clinicians, researchers, and most importantly, the CF community. Your experiences and voices continue to drive meaningful change.
Our work continues. CFA will keep advocating to ensure Alyftrek is subsidised through the PBS as soon as possible, so it is affordable and accessible to all who need it.
Together, we can shape a future where every Australian living with CF has the chance for a longer, healthier life.
To read further: https://www.tga.gov.au/resources/artg/452345