EMA, MHRA to review Vertex’ Kaftrio for children with CF
If approved, up to 2,000 children with CF would be eligible for treatment with the drug
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Tag: CF
Symkevi/Kalydeco cleared for use in young CF patients
The combination is the first available to treat the underlying cause of CF in this patient group.
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EU nod for Vertex CF therapy Kaftrio
Clearance was based on two global Phase III studies showing statistically significant improvements in lung function
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Vertex and NHS Wales agree on Kaftrio reimbursement
The letter of intent should secure access to the combination for people with cystic fibrosis upon its regulatory approval
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EU expands reach of Vertex’ CF drug Kalydeco
Kalydeco is the only approved medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation
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Campaigners call for NHS access to Orkambi as MP inquiry gets underway
Patients and campaigners took to the streets in London yesterday demanding NHS access to Vertex’ cystic fibrosis drugs, following a public hearing on the situation ordered by MPs.
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Vertex’ three-drug CF combo hits PhIII targets
Vertex’ three-drug cystic fibrosis regimen – combining the investigational next-generation corrector VX-445 with Kalydeco (ivacaftor) and tezacaftor – has achieved primary endpoints of two Phase III studies in patients the condition.
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Orkambi’s use expanded for younger children
The European Commission has expanded the use of Orkambi to include children with cystic fibrosis aged two years to five years.
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Kalydeco approved by EU for CF in 12-24 month olds
Vertex Pharmaceuticals says the European Commission has granted approval of the label extension for Kalydeco, to include the treatment of patients with cystic fibrosis (CF) aged 12 to 24 months.
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EU approves Vertex’ cystic fibrosis combo
The European Commission has approved Vertex’ Symveki in a combination regimen with Kalydeco to treat certain patients with cystic fibrosis (CF).
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Vertex, NHS England no closer to Orkambi settlement
Vertex and NHS England remain locked in a battle over the provision of cystic fibrosis drug Orkambi, seemingly no closer to a settlement that would allow patients access to the drug on the NHS.
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Vertex presents real-world data highlighting benefit of CF drug Kalydeco
Vertex has presented long-term, observational data highlighting the benefit of Kalydeco in patients with cystic fibrosis.
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