Kalydeco was initially approved in 2012 to treat patients aged over six with a single mutation of the cystic fibrosis transmembrane regulator (CFTR) gene - known as G551D - which affects around ...

This means that the lumacaftor-Kalydeco combination could have an even greater commercial potential than Kalydeco's current licensed use, although analysts doubt it can show the same level of ...

Ivacaftor oral granules, 25 mg, 50 mg and 75 mg (Kalydeco) had an estimated annual sale of USD 51 million in the US (IQVIA MAT November 2024).

Lupin also received tentative approval from the FDA for ivacaftor oral granules, 25 mg, 50 mg and 75 mg per unit dose packet, which is a generic of Vertex’s Kalydeco. Lupin is the exclusive ...

In March 2022, the Competition Commission launched an investigation into Vertex, alleging excessive pricing and exclusionary practices in its supply of cystic fibrosis drugs, including Kalydeco ...