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Date Title and Summary Additional Formats
Toggle Summary Vertex Announces European Authorization for Third Cystic Fibrosis Medicine SYMKEVI® (tezacaftor/ivacaftor), to be used in combination with ivacaftor (KALYDECO®), for People with CF Aged 12 and Older with Certain Mutations in the CFTR gene
- A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis - - First medicine in the EU to treat the CFTR protein defect in patients who have one copy of the F508del mutation and one copy of one of 14 mutations that result in residual
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Toggle Summary Vertex Announces European Commission Approval for KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in Combination With Ivacaftor to Treat Cystic Fibrosis Patients 12 Years and Older With At Least One F508del Mutation in the CFTR gene
- New indication includes people ages 12 years and older who have one copy of the F508del mutation regardless of the other mutation type - - People with gating (F/G) or residual function (F/RF) mutations now eligible for the triple combination therapy - LONDON --(BUSINESS WIRE)--Apr.
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With Cystic Fibrosis as Early as Four Months of Age
- Approval provides opportunity to treat the underlying cause of cystic fibrosis earlier than ever before in Europe - LONDON --(BUSINESS WIRE)--Nov. 5, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the European Commission has granted approval of the label extension
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) for Children and Adolescents With Cystic Fibrosis Between the Ages of 6 Months and 18 Years With the R117H Mutation in the CFTR Gene
- KALYDECO ® (ivacaftor) is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in patients with the R117H mutation, the most common residual function mutation, in children as young as 6 months of age - LONDON --(BUSINESS WIRE)--Jun.
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) in Infants With Cystic Fibrosis Ages 6 Months to Less Than 12 Months With Certain Mutations in the CFTR Gene
- Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in children this young - LONDON --(BUSINESS WIRE)--Dec. 10, 2019-- Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® (ivacaftor) to Treat Patients with Cystic Fibrosis Aged 12 to <24 months with Certain Mutations in the CFTR Gene
Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis in these young patients LONDON --(BUSINESS WIRE)--Nov. 29, 2018-- Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label
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Toggle Summary Vertex Announces European Commission Approval for KALYDECO® to Treat Infants With Cystic Fibrosis Ages 1 Month and Older
-   KALYDECO   ® is the first and only medicine approved in the EU in this age group to treat the underlying cause of cystic fibrosis for specific mutations in the CFTR gene - LONDON --(BUSINESS WIRE)--Apr. 26, 2024-- Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European
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Toggle Summary Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
Lumacaftor/ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic fibrosis for approximately 1,500 children aged 2 to 5 with two copies of the F508del mutation LONDON --(BUSINESS WIRE)--Jan. 21, 2019-- Vertex Pharmaceuticals (Europe) Limited today
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Toggle Summary Vertex Announces European Commission Approval for SYMKEVI® (tezacaftor/ivacaftor) With KALYDECO® (ivacaftor) for Eligible Children With Cystic Fibrosis Ages 6-11 Years
- The combination therapy is a new treatment option for CF patients who are homozygous for F508del - - The only medicine to treat the underlying cause of CF in this age group with one F508del mutation and one of 14 residual function mutations - LONDON --(BUSINESS WIRE)--Nov.
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Toggle Summary Vertex Announces European Medicines Agency Marketing Authorization Application Validation for VX-445 (Elexacaftor), Tezacaftor and Ivacaftor Triple Combination Treatment in Cystic Fibrosis
- Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations - LONDON --(BUSINESS WIRE)--Oct.
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