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Vertex : EU Approves KAFTRIO-Ivacaftor To Treat Cystic Fibrosis In People Ages 12 Years And Older

Vertex Pharmaceuticals Inc. (VRTX) said Friday that the European Commission has approved KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor to treat people with cystic fibrosis ages 12 years and older.

The company noted that maximum 10,000 people in Europe ages 12 years and older with one F508del mutation and one minimal function mutation will be eligible for a medicine that treats the underlying cause of cystic fibrosis.

According to the company, people 12 years of age and older who have two F508del mutations will also be eligible for the new triple combination regimen.

As a result of long-term reimbursement agreements in England, Denmark and the Republic of Ireland, and provisions for access in health care systems such as Germany, eligible patients in those countries will have access to the triple combination regimen in the upcoming weeks, Vertex said in a statement.

Vertex said it is working closely with national health authorities and governments in all other countries in Europe to secure access for eligible patients as quickly as possible.

Cystic Fibrosis is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. Cystic Fibrosis is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract.

Cystic Fibrosis is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene.

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