Thursday 16 October 2025

Medsafe grants approval for ALYFTREK: A new era in cystic fibrosis treatment in New Zealand.

Auckland, 16 October 2025 – Cystic Fibrosis NZ welcomes Medsafe’s approval of ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), a once-daily CFTR modulator therapy for people aged six years and older with cystic fibrosis (CF) who have at least one F508del mutation or other responsive mutation.

This milestone marks a significant advancement in CF care, expanding therapeutic options for people with CF in New Zealand. The approval of ALYFTREK reflects the growing momentum toward precision medicine and providing equitable access to all New Zealanders living with CF.

Lisa Burns, Chief Executive of Cystic Fibrosis NZ (CFNZ) said “New Zealand is now one of the first countries in the world to have registration, and this provides potential to be one of the first countries in the world with access. This approval is more than a regulatory process, it’s a signal of hope for the future of modern medicines. ALYFTREK offers a new pathway and provides options to those patients who may not benefit from existing therapies.

New Zealand has been inherently slow to register and fund medicines but the speed of assessment of ALYFTREK is a demonstration of what’s possible. CFNZ thanks Medsafe for approving ALYFTREK so quickly and efficiently.

We have seen since April 2023 when TRIKAFTA was funded for those aged six years and over, just how transformative this has been for hundreds of people living with CF. It has fundamentally shifted CF care from being predominantly inpatient to outpatient focused. Within the first six months of funded access to TRIKAFTA, CFNZ saw a 50% reduction in inpatient visits from their Social Workers due to fewer hospital admissions.

CFNZ again urges Pharmac to act without delay to provide access to ALYFTREK, alongside Trikafta for 2- to 5-year-olds, and widened access to KALYDECO. This would give equitable access to all people with CF who would benefit from a CF modulator therapy. 

“This approval from Medsafe aligns New Zealand with international efforts to broaden access to transformative CF therapies and reinforces our commitment to improving outcomes for every person living with CF in Aotearoa,” said Lisa.

CFNZ remains committed to advocating for timely and equitable access to modern CF treatments, ensuring all New Zealanders with CF have the opportunity to live well and thrive.

ENDS

Download the media release here >