LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals today announced that the European Commission has granted approval for the label extension of ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) ages 1 to <2 years old who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, the most common form of the disease.
Vertex Pharmaceuticals VRTX announced that the FDA approved the expanded use of its cystic fibrosis (CF) drug Orkambi (lumacaftor/ivacaftor) in children aged 12 months to less than 24 months.
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of ORKAMBI® (lumacaftor/ivacaftor) to include children with cystic fibrosis (CF) ages 12 to <24 months who are homozygous for the F508del mutation (F/F genotype) in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. ORKAMBI® was previously approved by the FDA for use in people with CF ages 2 years and older with two copies of the F508del mutation.
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.
LONDON--(BUSINESS WIRE)--Apr. 21, 2020-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has reached an agreement with the Swiss Federal Office of Public Health (FOPH) and the Swiss Federal Social Insurance Office (FSIO) for the reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for eligible patients in Switzerland living with cystic fibrosis (CF).
LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it has reached an agreement with the Swiss Federal Office of Public Health (FOPH) and the Swiss Federal Social Insurance Office (FSIO) for the reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for eligible patients in Switzerland living with cystic fibrosis (CF).
Vertex Pharmaceuticals Inc’s drugs for lung condition cystic fibrosis will now be available to patients across the UK after the company reached a pricing deal with Wales on Wednesday.
After drawn out negotiations and much discontent among cystic fibrosis (CF) patients and their advocates, Vertex has announced that a deal has finally been reached that will make its crucial CF medications available to patients across Wales and Northern Ireland.
Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that the Spanish Government has approved terms for the national reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor) in combination with KALYDECO® (ivacaftor) for eligible patients in Spain living with cystic fibrosis (CF).