Expanded access for Vertex's latest CF drug

24 June 2019
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Vertex Pharmaceuticals (Nasdaq: VRTX) continues to clock up regulatory approvals for its cystic fibrosis (CF) medicines.

The US drugmaker has received approval from the US Food and Drug Administration (FDA) for expanded usage of Symdeko (tezacaftor/ivacaftor and ivacaftor), its third medicine to treat the underlying cause of CF.

This increases the label to include children with CF aged six through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the CF transmembrane conductance regulator (CFTR) gene that is responsive to Symdeko.

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