Vertex Pharmaceuticals' (VRTX) triple combination medicine deutivacaftor, tezacaftor,vanzacaftor was approved by the UK's Medicines and Healthcare products Regulatory Agency for treating cystic fibrosis in patients aged six and older with responsive CFTR mutations, including F508del, the agency said in a statement on Friday.
The treatment is marketed under the brand name of Alyftrek.
Two randomized phase 3 studies involving 480 participants aged 12 years and older, Alyftrek was found to be as effective at improving lung function as ivacaftor/tezacaftor/elexacaftor or Kaftrio, and more effective at reducing sweat chloride levels compared to placebo.
The agency said grapefruit-containing food or drink should be avoided during treatment.
The drug's common side effects include headache and diarrhoea.
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