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European Commission approves cystic fibrosis treatment for six to 11-year-olds
pharmatimes
January 11, 2022
There is currently no cure for cystic fibrosis (CF), a debilitating, progressive condition with over 10,830 people in the UK currently diagnosed with the disease.
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MHRA approves label extension for Vertex’s Kaftrio combo
pharmatimes
May 12, 2021
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a label extension for Vertex’s cystic fibrosis (CF) treatment Kaftrio in combination with ivacaftor.
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Triple combo cystic fibrosis therapy Kaftrio scores EU label expansion
pharmatimes
April 30, 2021
The European Commission (EC) has approved a label extension for Vertex’s triple combination cystic fibrosis (CF) treatment Kaftrio, extending its use for the ‘majority’ of patients aged 12 years and older in Europe.
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Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
europeanpharmaceuticalreview
August 27, 2020
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
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EC approves Vertex’s Kaftrio plus ivacaftor for cystic fibrosis patients
pharmaceutical-technology
August 25, 2020
Vertex Pharmaceuticals has secured approval from the European Commission (EC) for the use of Kaftrio (ivacaftor / tezacaftor / elexacaftor) in combination with ivacaftor for the treatment of cystic fibrosis (CF).
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Vertex Submits New Drug Application to the U.S. FDA for Triple Combination Regimen of VX-445 (Elexacaftor), Tezacaftor and Ivacaftor in Cystic Fibrosis
drugs
July 24, 2019
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the submission of a New Drug Application (NDA) to the...
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Key Cystic Fibrosis Pathogens Reduced With Ivacaftor Use
drugs
July 22, 2019
For patients with cystic fibrosis (CF), ivacaftor use is associated with a reduction in pathogens, including Pseudomonas aeruginosa...
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FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene
drugs
June 24, 2019
FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene.
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Vertex reports preliminary data for triple combination cystic fibrosis therapy
pharmaceutical-technology
March 08, 2019
Boston-based pharmaceutical company Vertex has published promising interim analysis from two Phase III studies of a triple combination therapy of VX-445, tezacaftor and ivacaftor for cystic fibrosis.