Vertex: European Commission Approves KALYDECO To Treat Infants With Cystic Fibrosis

(RTTNews) - Vertex Pharmaceuticals Incorporated (VRTX) announced the European Commission has granted approval of the label extension for KALYDECO (ivacaftor) granules to include the treatment of infants with cystic fibrosis ages 4 months and older. The company said the label update is based on data from a cohort in the 24-week phase 3 open-label safety study (ARRIVAL) consisting of six children with cystic fibrosis ages four months to less than six months who have eligible gating mutations.

KALYDECO will be now available to additional eligible patients in Germany and will be available shortly in countries that have entered into long-term reimbursement agreements with Vertex, including the UK, Denmark and the Republic of Ireland.