Vertex Pharmaceuticals announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for ALYFTREK (deutivacaftor/tezacaftor/vanzacaftor). This is a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator treatment.
The approval is for people living with cystic fibrosis (CF) aged 6 years and older who have at least one F508del mutation or another responsive mutation in the CFTR gene. This includes additional mutations not previously approved with other CFTR modulator therapies.
In head-to-head clinical trials, deutivacaftor/tezacaftor/vanzacaftor was non-inferior on ppFEV1 and further decreased sweat chloride compared to ivacaftor/tezacaftor/elexacaftor. Vertex is working with the National Institute for Health and Care Excellence (NICE) and the NHS to ensure eligible patients can access this new therapy.
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