FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis

☞ | View the text of this post. Exclusively available to ASQ Members.

The U.S. Food and Drug Administration (FDA) 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

0 replies

Leave a Reply

Want to join the discussion?
Feel free to contribute!

Leave a Reply

Your email address will not be published. Required fields are marked *