Alyftrek is a triple combination CFTR modulator comprised of deutivacaftor, tezacaftor and vanzacaftor.

RT’s Three Key Takeaways:

  1. Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) approved in the EU for people with CF 6 years and older with at least one non-class I mutation in the CFTR gene, making it the broadest label for this medicine in the world
  2. In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and superior compared to Kaftrio (ivacaftor/tezacaftor/elexacaftor) at reducing sweat chloride, demonstrating greater improvement in CFTR function.
  3. Approximately 31,000 people with CF in the EU are now eligible for this new highly effective modulator therapy.


The European Commission has granted approval for Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) for the treatment of people with cystic fibrosis (CF) ages 6 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, according to Vertex Pharma.

Alyftrek is a triple combination CFTR modulator comprised of deutivacaftor, tezacaftor and vanzacaftor.

  • Vanzacaftor and tezacaftor are designed to increase the amount of CFTR protein at the cell surface by facilitating the processing and trafficking of the CFTR protein.
  • Deutivacaftor is a potentiator designed to increase the channel open probability of the CFTR protein delivered to the cell surface to improve the flow of salt and water across the cell membrane.

In two head-to-head pivotal clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior to Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor on ppFEV1 and superior at reducing sweat chloride, demonstrating greater improvement in CFTR function.

“Thousands of people with CF across the EU may now benefit from this new, once-daily medicine, which has demonstrated further improvement in CFTR protein function versus Kaftrio,” said Reshma Kewalramani, MD, CEO and president of Vertex. “With this approval, we are one step closer to our ultimate goal of restoring normal levels of CFTR function in people living with CF.”

“CF care has been transformed by the advent of highly effective CFTR modulators, and I am very pleased that we now have a new treatment option to even better address this multi-systemic disease,” said Professor Marcus A. Mall, MD, Professor and Chair of the Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine and Cystic Fibrosis Center at Charité Universitätsmedizin Berlin. “Deutivacaftor/tezacaftor/vanzacaftor has shown it can deliver greater reductions in sweat chloride compared to standard of care. By bringing more people closer to normal level of CFTR function, this new medicine has the potential to further improve outcomes for patients.”

As a result of reimbursement agreements in Ireland and Denmark and provisions for access in healthcare systems such as Germany, eligible patients in these countries will have access to deutivacaftor/tezacaftor/vanzacaftor shortly following regulatory approval by the European Commission. Vertex will continue to work with reimbursement bodies across the European Union member states to ensure access for all eligible patients as quickly as possible.