FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis

News Release

 

FDA expands approved use of Kalydeco to treat additional mutations of cystic fibrosis

05/17/2017 04:14 PM EDT

The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis. The approval triples the number of rare gene mutations that the drug can now treat, expanding the indication from the treatment of 10 mutations, to 33. The agency based its decision, in part, on the results of laboratory testing, which it used in conjunction with evidence from earlier human clinical trials. The approach provides a pathway for adding additional, rare mutations of the disease, based on laboratory data.

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