The European Commission (EC) has granted approval for the label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor), in a combination regimen with ivacaftor.
LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the Spanish government has approved terms for the national reimbursement of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for the treatment of cystic fibrosis (CF) for eligible patients. The agreement covers people with CF ages 12 years and older who have at least one copy of the F508del mutation, regardless of the other mutation type in the CFTR gene. KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor can be prescribed to eligible patients by treating physicians once the medicine is listed in the national Official Gazette Nomenclator.
BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) expanded the eligibility for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include people with cystic fibrosis (CF) ages 12 years and older with certain mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that are responsive to TRIKAFTA based on in vitro data. SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) and KALYDECO® (ivacaftor) also received approvals to include additional responsive mutations in people with CF ages 6 years and older and age 4 months and older, respectively. These approvals allow more than 600 people with CF not previously eligible for these medicines an opportunity to potentially benefit from treatment that targets the underlying cause of their disease.
The European Commission as approved use of Vertex' Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for eligible children with cystic fibrosis (CF) aged 6-11 years.
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data from the company’s portfolio of cystic fibrosis (CF) medicines will be presented at the 43rd European Cystic Fibrosis Digital Conference (ECFS) held September 24-25, 2020 and the 2020 North American Cystic Fibrosis Virtual Conference (NACFC) taking place October 7-23, 2020. An oral presentation at the ECFS Digital Conference will highlight, for the first time, interim results from the TRIKAFTA open-label extension study, which showed safety and efficacy consistent with the results of the Phase 3 pivotal studies in patients with CF ages 12 and older with F508del/Minimal Function (F/MF) or F508del/F508del (F/F) genotypes. Four additional scientific abstracts for ORKAMBI® and TRIKAFTA® were published in the Journal of Cystic Fibrosis as part of the ECFS conference. In addition, six scientific presentations will occur at NACFC regarding KALYDECO,® ORKAMBI and TRIKAFTA, including new data from KALYDECO in infants ages 4 to less than 6 months old.
BOSTON, September 23, 2020 – The Institute for Clinical and Economic Review (ICER) today released a Final Evidence Report and Report-at-a-Glance assessing the comparative clinical effectiveness and value of elexacaftor/tezacaftor/ivacaftor (Trikafta®, Vertex Pharmaceuticals) for the treatment of cystic fibrosis (CF). ICER also examined new data that have become available since its May 2018 review of three related CF treatments: ivacaftor (Kalydeco®, Vertex), lumacaftor/ivacaftor (Orkambi®, Vertex), and tezacaftor/ivacaftor (Symdeko®, Vertex). All four therapies are CFTR modulators. ICER’s report on these therapies was reviewed at the August 2020 public meeting of the California Technology Assessment Forum (CTAF), one of ICER’s three independent evidence appraisal committees. Vertex was invited to share the company’s perspective at the public meeting but declined to participate.
Vertex Pharmaceutical's Kaftrio (ivacaftor / tezacaftor / elexacaftor) Receives Approval In Europe
The European Commission (EC) has approved Vertex Pharmaceuticals’ Kaftrio (ivacaftor/tezacaftor/elexacaftor) for use in combination with ivacaftor to treat people aged 12 plus with certain forms of cystic fibrosis (CF).
Vertex Pharmaceuticals' Kaftrio (ivacaftor/tezacaftor/elexacaftor) has been approved by the European Commission for use in combination with ivacaftor to treat people aged 12 years and older with certain forms of cystic fibrosis.
The company has agreed a letter of intent with NHS Wales to expand its reimbursement agreement for CF medicines to include Kaftrio (ivacaftor/tezacaftor/elexacaftor), in a combination regimen with ivacaftor 150 mg, upon the medicine’s anticipated marketing clearance by the European Commission.