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Press Releases

Date	Title and Summary	Additional Formats
Toggle SummaryMay 23, 2011	FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C -79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment- -Vertex launches a comprehensive financial assistance and patient support program- -Conference call today at 11:00 a.m. ET to provide more information on the commercialization of INCIVEK- HCV	View HTML FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C 150.7 KB
Toggle SummarySep 25, 2020	FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age -Approval provides opportunity to treat the underlying cause of CF earlier than ever before- -Safety data from a cohort of the Phase 3 ARRIVAL study support treatment with KALYDECO in children ages four to General Business	View HTML PDF Version
Toggle SummaryApr 30, 2019	FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age -Opportunity to treat the underlying cause of CF earlier than ever before- -Safety data from Phase 3 ARRIVAL study support treatment with KALYDECO in children ages six to General Business	View HTML PDF Version
Toggle SummaryAug 15, 2018	FDA Approves KALYDECO® (ivacaftor) as First and Only Medicine to Treat the Underlying Cause of CF in Children Ages 12 to <24 Months with Certain Mutations in the CFTR Gene -Data from Phase 3 ARRIVAL study support treatment with KALYDECO in children ages 12 to General Business	View HTML PDF Version
Toggle SummaryAug 1, 2017	FDA Approves KALYDECO® (ivacaftor) for More Than 600 People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO ® (ivacaftor) for use in more than 600 people with cystic fibrosis (CF) ages 2 and older who have one of five residual function General Business	View HTML FDA Approves KALYDECO® (ivacaftor) for More Than 600 People Ages 2 and Older With Cystic Fibrosis Who Have Certain Residual Function Mutations 24.4 KB
Toggle SummaryMay 17, 2017	FDA Approves KALYDECO® (ivacaftor) for More Than 900 People Ages 2 and Older with Cystic Fibrosis Who Have Certain Residual Function Mutations - Precision medicine decision based on in vitro data and supported by more than five years of real-world clinical data that demonstrate KALYDECO's strong safety and efficacy profile for eligible patients - - Vertex working with FDA to obtain rapid approval for more than 600 additional people who General Business	View HTML FDA Approves KALYDECO® (ivacaftor) for More Than 900 People Ages 2 and Older with Cystic Fibrosis Who Have Certain Residual Function Mutations 26.5 KB
Toggle SummaryJan 31, 2012	FDA Approves KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis - FDA approval received 3 months after submission of New Drug Application - - KALYDECO approved to treat people with CF who have a specific genetic mutation - - Vertex launches a comprehensive financial assistance and patient support program - CAMBRIDGE, Mass. Cystic Fibrosis	View HTML ADDING MULTIMEDIA FDA Approves KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis 165.1 KB
Toggle SummaryAug 7, 2018	FDA Approves ORKAMBI® (lumacaftor/ivacaftor) as First Medicine to Treat the Underlying Cause of Cystic Fibrosis for Children Ages 2-5 Years with Most Common Form of the Disease - Approximately 1,300 people in the U.S. ages 2 through 5 years have two copies of the F508del mutation, the most common genetic form of the disease - BOSTON --(BUSINESS WIRE)--Aug. 7, 2018-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. General Business	View HTML PDF Version
Toggle SummaryJul 2, 2015	FDA Approves ORKAMBI™ (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation -Approximately 8,500 people in the U.S. are ages 12 and older and have two copies of the F508del mutation, the most common genetic form of the disease- BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Cystic Fibrosis	View HTML FDA Approves ORKAMBI™ (lumacaftor/ivacaftor) - the First Medicine to Treat the Underlying Cause of Cystic Fibrosis for People Ages 12 and Older with Two Copies of the F508del Mutation 29.4 KB
Toggle SummaryFeb 12, 2018	FDA Approves SYMDEKOTM (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene - SYMDEKO is Vertex's third medicine to treat the underlying cause of CF - - SYMDEKO to begin shipping to pharmacies this week - BOSTON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved SYMDEKO ™ General Business	View HTML FDA Approves SYMDEKOTM (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene 102.7 KB