FDA rejects Vertex's application for expanded use of drug

FDA has denied the expanded use of Vertex Pharmaceutical’s bestseller ivacaftor (Kalydeco) in certain cystic fibrosis patients. The regulator rejected the company’s application for using the drug in cystic fibrosis patients aged 2 years or older, who have one of 23 residual function mutations. The company said in a statement that it “plans to meet with FDA to determine an appropriate path forward.” FDA’s action does not preclude Vertex from submitting another application based on new clinical data.