European CHMP recommends approval of extension to existing indication for Kalydeco (ivacaftor) and new tablet strength
The CHMP has recommended the approval of a new 75mg strength for Kalydeco tablets and an extension to the existing indication in combination with Symkevi (tezacaftor/ivacaftor) to allow use in children from 6 years of age (currently 12 years).
Source:
European Medicines Agency
SPS commentary:
The CHMP has also recommended the approval of an extension to the existing indication of the granules, to allow use in infants aged at least 4 months (currently 6 months).