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: ivacaftor
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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Vertex signs ‘landmark’ deal with NHS for CF therapy
CF patients in England will be among the first in Europe to benefit from access to Kaftrio, if the medicine is approved by the EC
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Eight medicines leap towards EU approval
The recommendations include a conditional approval for Gilead’s Veklury (remdesivir) for COVID-19
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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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EU expands scope of Vertex’ Kalydeco
Children with cystic fibrosis as young as six months with certain mutations can now access the treatment
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FDA expansion for Symdeko in cystic fibrosis
The indication is now for pediatric patients ages six years and older with certain genetic mutations.
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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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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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MPs order release of documents on negotiations for Vertex’ CF drugs
The UK House of Commons’ Health and Social Care Committee has requested documents and evidence from Vertex Pharmaceuticals, NHS England and the National Institute for Health and Care Excellence (NICE) regarding ongoing and lengthy negotiations about NHS funding for the firm’s cystic fibrosis treatments.
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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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