Vertex to Seek Expanded FDA Approval for Trikafta After Positive Child Safety Data
Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is safe for use in children with cystic fibrosis (CF) as young as age 6, data...
Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis...
Women With CF Use Combined Hormonal Contraceptives More Than Other Methods, Study Reports
Among women of childbearing age with cystic fibrosis (CF), the use of combined hormonal contraceptives containing both estrogen and...
CHMP Gives Positive Opinion to Vertex’s Triple Combination Therapy Kaftrio
The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in...
Kalydeco Approved in Europe to Treat Children with R117H Mutation
The European Commission has approved Vertex’s Kalydeco (ivacaftor) for the treatment of children and adolescents with cystic fibrosis...
Planned CHOICES Trial in Rare CF Mutations Given Regulatory Support
Proteostasis Therapeutics reported receiving scientific advice for its CHOICES clinical trial program, which is to test its personalized...
UK NICE to Announce Decision on Vertex’s Therapy Trikafta in December
The National Institute for Health and Care Excellence (NICE) in the U.K. is currently in the process of evaluating Vertex...
Vertex Announces Availability of Cystic Fibrosis Medicine KALYDECO® (ivacaftor) in New Zealand
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that KALYDECO® (ivacaftor) will be available to eligible patients with...
CF patients experience improved lung health with lumacaftor-ivacaftor but with caveats
In adolescent and adult patients with cystic fibrosis taking lumacaftor-ivacaftor (ORKAMBI), the combination drug appears to improve lung...
FDA to Review Elexacaftor, Tezacaftor, Ivacaftor Combo for Cystic Fibrosis
The Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA) for elexacaftor (VX-445),...
