Medsafe has given consent for the use of Trikafta to treat cystic fibrosis in patients in New Zealand.
Pharmaceuticals company Vertex on Thursday announced the consent, saying more than 350 Kiwis will now be eligible to receive the treatment.
The drug is available to cystic fibrosis patients six and over who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
"We appreciate Trikafta receiving a Priority Review and the subsequent completion of the review in just six months is extraordinary," said Simon Lem, Vertex's regional vice president for Northern Europe, Australia and New Zealand.
"This is a significant milestone in our efforts to bring our medicines to eligible New Zealanders with CF."
More than 350 patients are now eligible for treatment for the first time, Vertex says.
It marks the first regulatory approval outside the United States for Trikafta for use in patients ages six and over.
Vertex made a reimbursement application in July 2021 for the medicine to be funded for use by New Zealand patients ages six and over, and Pharmac launched a parallel review. Pharmac recommended it should be a high priority for funding.