MHRA licenses cystic fibrosis drugs Kaftrio and Kalydeco for infants

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has today extended the license of the cystic fibrosis medicines Kaftrio (ivacaftor, tezacaftor and elexacaftor) and Kalydeco (ivacaftor) for children aged two to five years old.

The new indication was granted to the local subsidiary of US biopharma company Vertex Pharmaceuticals (Nasdaq: VRTX), which last year reported global sales of Kalydeco of $553 million.

These medicines were already authorized for use in treating cystic fibrosis with a common gene mutation in patients aged six years and older, and today’s announcement extends that authorization.