Vertex Pharmaceuticals has won approval in Canada for Kalydeco (ivacaftor) to include use in 1-2 year olds with cystic fibrosis (CF), with certain genetic modifications.
The label update is based on data from the ongoing Phase III ARRIVAL study. The label expansion has already been granted in the USA and in Europe.
Chief medical officer Reshma Kewalramani said: “We look forward to working with the Canadian health officials and provinces to achieve rapid access to Kalydeco for this small, but important group of young children.”
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