Kalydeco Receives Expanded Indication
August 15, 2018 – The U.S. FDA has approved an expanded indication for Kalydeco® (ivacaftor), manufactured by Vertex Pharmaceuticals, to treat pediatric cystic fibrosis patients who are at least one year old and weigh a minimum of 7kg (15 pounds). Patients eligible for treatment with Kalydeco must have a cystic fibrosis transmembrane conductance regulator (CFTR) mutation known to respond to the medication.
Prior to the expanded indication, Kalydeco was approved for use in patients no younger than two years old. Recommended dosing for children under six years of age is based on weight. For patients in this age group, the medication’s oral granule dosage form should be used, and can be mixed with soft food or liquid for administration. Patients should consume a fat-containing food with each dose. Oral tablets are available for adults and children who are at least six years old.
Kalydeco first received FDA approval in 2012. It treats cystic fibrosis by helping to improve the transport of chloride ions in the body.