- Precision medicine decision based on in vitro data and supported by more than five years of real-world clinical data that demonstrate KALYDECO’s strong safety and efficacy profile for eligible patients -
- Vertex working with FDA to obtain rapid approval for more than 600 additional people who have mutations responsive to KALYDECO, including one of five “splice” mutations -
BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved KALYDECO® (ivacaftor) for use in people with cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. This precision medicine decision is based on analyses of in vitro data and is supported by more than five years of real-world clinical data that demonstrate KALYDECO’s strong safety and efficacy profile. More than 900 people ages 2 and older in the U.S. have one of these mutations. Based on this approval, Vertex today increased its guidance for 2017 product revenues of KALYDECO to a range of $740 million to $770 million.
