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Vertex: EU Approves SYMKEVI With KALYDECO For 6-11 Years Children With Cystic Fibrosis

Vertex Pharmaceuticals Incorporated (VRTX) announced Friday that the European Commission has granted approval of the label extension for SYMKEVI (tezacaftor/ivacaftor) with KALYDECO (ivacaftor) for eligible children with Cystic Fibrosis or CF ages 6-11 years.

CF is a rare, life-shortening genetic disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene.

The approval is for the treatment of CF in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator or CFTR gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity.

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

In all other countries, Vertex will work closely with relevant authorities in Europe to secure access for eligible patients.

In Europe, SYMKEVI with KALYDECO is already approved for the treatment of people with CF ages 12 years and older who have either two copies of the F508del mutation in the CFTR gene, or one copy of the F508del mutation and a copy of one of the 14 mutations in which the CFTR gene results in residual CFTR protein activity.

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