21 June 2021
Vertex has submitted its application to Medsafe for approval of its triple combination therapy - registered in Australia as Trikafta.
The application is for the treatment of CF in people 6 years and older. Medsafe has accepted the application and granted it priority status, enabling a shorter time for evaluation.
Vertex has also submitted an application to Medsafe for approval of lumacaftor/ivacaftor - registered in Australia as Orkambi. Together with its application to Medsafe for approval of Symdeko earlier this year, Vertex has made applications for all three of its CF modulator therapies that are not yet approved and funded in New Zealand.
Cystic Fibrosis NZ is absolutely delighted that Vertex’s application for Trikafta has been submitted to Medsafe and we look forward to an application to Pharmac in the very near future. Pharmac and Medsafe have already agreed to consider the applications in parallel.