Vertex gets FDA nod to Kalydeco for cystic fibrosis in 4 to 6-month infants

The FDA has approved Vertex Pharmaceuticals' (NASDAQ:VRTX) Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) aged four months to less than six months old, with at least one cystic fibrosis transmembrane conductance regulator gene mutation, that is responsive to Kalydeco based on clinical and/or in vitro assay data.

Kalydeco is already approved in the U.S. and EU for the treatment of CF in patients ages six months and older

Vertex' three supplemental marketing applications were accepted by the FDA. Also Moderna and Vertex collaborated on gene editing therapies for CF.

https://seekingalpha.com/news/3617298-vertex-gets-fda-nod-to-kalydeco-for-cystic-fibrosis-in-4-to-6-month-infants