Game-changing cystic fibrosis drug has been fast-tracked and approved by the US FDA, and is under review by the EMA
Image as seen on Vertex website
Vertex Pharmaceuticals has confirmed that it has negotiated an agreement for the use of Trikafta in the Republic of Ireland. Following recent collaborative discussions, the Health Service Executive (HSE) in the Republic of Ireland has agreed to expand existing long-term cystic fibrosis (CF) reimbursement to include Trikafta, the triple combination regimen (elexacaftor, tezacaftor and ivacaftor), which is under review and pending approval by the EMA.
The deal will cover all eligible patients ages 12 and older in line with the potential future licensed indication. The drug has already shown life-changing results in CF sufferers in the US, and the hope is that it will so be approved and available in Europe.
The agreement expands the existing agreement, which had already included access to current and future Vertex medicines for people in Ireland with CF of any age who have certain mutations. In the case of Trikafta, this covers 90% of those with CF
This innovative long-term agreement also enabled rapid access for people with the appropriate mutations if the labels of the existing medicines were expanded to cover additional age groups and if new Vertex medicines were approved for these populations.
Ludovic Fenaux, Senior VP of Vertex International, said: “With this expanded agreement, even more patients in the Republic of Ireland will be among the first in Europe to benefit from the triple combination treatment once the medicine is licensed.”
The new CFTR modulator is not currently licensed for use in the EU. Vertex submitted a Marketing Authorization Application to the EMA on 31 October 2019.