Vertex Pharmaceuticals announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor), a once-daily cystic fibrosis treatment for patients aged 6 and older with at least one responsive mutation in the CFTR gene. The approval expands access to additional mutations not covered by previous CFTR modulator therapies.

In clinical trials, Alyftrek demonstrated non-inferiority in lung function (ppFEV1) and further reduced sweat chloride levels compared to the existing combination therapy of ivacaftor/tezacaftor/elexacaftor with ivacaftor. Researchers hope these improvements will lead to a lower risk of CF-related complications over time.

Vertex is working with the UK’s National Institute for Health and Care Excellence (NICE) and the NHS to make the therapy available to eligible patients as soon as possible. The drug was approved by the U.S. FDA in December 2024, and regulatory reviews are ongoing in Europe, Canada, Switzerland, Australia, and New Zealand.

Vertex continues to be a leader in CF treatment, with over 68,000 patients currently using its therapies across more than 60 countries. The company remains focused on advancing its pipeline in CF and other serious diseases.