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Toggle Summary Vertex Receives Australian TGA Approval for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to Treat People With Cystic Fibrosis Ages 12 Years and Older Who Have At Least One F508del Mutation
- With this approval approximately 750 people living with cystic fibrosis in Australia will be newly eligible for a CFTR modulator therapy - LONDON --(BUSINESS WIRE)--Mar. 24, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Australian Therapeutic Goods
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Toggle Summary Vertex Receives Australian Approval for ORKAMBI® (lumacaftor/ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People Ages 12 and Older with Two Copies of the F508del Mutation
-In Australia, approximately 1,000 people with CF ages 12 and older have two copies of the F508del mutation- -ORKAMBI reimbursement process already underway in Australia - LONDON --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Therapeutic Goods
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Toggle Summary Vertex Receives Australian Approval for KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People with a Specific Genetic Mutation (G551D)
-- Approximately 250 people in Australia have the G551D mutation in the CFTR gene -- CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Therapeutic Goods Administration (TGA) of Australia has approved KALYDECO™ (ivacaftor) for people
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Toggle Summary Vertex Receives Approval for SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) in Australia, to Treat the Underlying Cause of Cystic Fibrosis in People aged 12 and Older with Certain CFTR Gene Mutations
-A new treatment option for patients with two copies of the F508del mutation, the most common mutation in cystic fibrosis- -First medicine in Australia to treat the underlying cause of cystic fibrosis in patients who have certain mutations that result in residual CFTR function- BOSTON --(BUSINESS
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Toggle Summary Vertex Receives a Positive PBAC Recommendation for Reimbursement of ORKAMBI® (lumacaftor/ivacaftor) to Treat Australians Ages Six and Over with Cystic Fibrosis and Two Copies of the F508del Mutation
- PBAC recommendation moves approximately 1,300 patients in Australia closer to access to lumacaftor/ivacaftor and Vertex is now working with the Australian Government to finalize a reimbursement agreement as soon as possible - LONDON --(BUSINESS WIRE)--Aug.
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Toggle Summary Vertex Provides Update to Ongoing Phase 2 Study Evaluating Combinations of Telaprevir and VX-222 for the Treatment of Hepatitis C
-Two-drug treatment arm of telaprevir and VX-222 alone discontinued- -Study continues with three arms, including all-oral combination of Vertex's lead protease and polymerase inhibitors with ribavirin- -Both of the four-drug treatment arms are fully enrolled; the majority of patients in these arms
HCV
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Toggle Summary Vertex Provides Update on Ongoing Phase 3 Program for VX-661 in Combination with Ivacaftor for the Treatment of Cystic Fibrosis
-Results from Part A of Phase 3 study in people with a mutation that results in minimal cystic fibrosis transmembrane conductance regulator (CFTR) protein function do not support continuation of the study- -Enrollment complete in Phase 3 study in people with two copies of the F508del mutation-
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Toggle Summary Vertex Provides Update on Ongoing All-Oral Studies of VX-135 in Hepatitis C
-U.S. Study: FDA places partial clinical hold on ongoing Phase 2 U.S. study of VX-135, preventing evaluation of 200 mg dose following observation of elevated liver enzymes in patients receiving 400 mg of VX-135 in combination with ribavirin in Phase 2 study in Europe ; evaluation of 100 mg dose
HCV
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Toggle Summary Vertex Provides Update on its Clinical Programs Targeting Alpha-1 Antitrypsin Deficiency
- Phase 2 study of VX-814 in patients with alpha-1 antitrypsin deficiency discontinued based upon safety and pharmacokinetic data - - Phase 2 study of VX-864 continues to enroll and dose patients; data expected in H1 2021 - - AATD research program continues to progress - BOSTON --(BUSINESS
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Toggle Summary Vertex Provides Update on Business and Financial Performance and Research and Development Programs
-Full-year 2016 product revenues of approximately $703 million for KALYDECO and $979 million for ORKAMBI; total 2016 CF product revenues of $1.68 billion compared to $983 million in 2015- -Company provides 2017 financial guidance for KALYDECO product revenues of $690 to $710 million and ORKAMBI
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