FDA Expands Approved Use of Kalydeco
May 17, 2017 – The U.S. FDA has expanded the approved use of Kalydeco® (ivacaftor - Vertex), a product for treating cystic fibrosis (CF) in patients at least 2 years of age. Previously, it was indicated for use in patients who had one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The new indication has expanded use to include patients who have one mutation in the CFTR gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. This expanded indication increases treatment to include 33 mutations, impacting an additional estimated 900 patients.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.