Expanded Indication for Kalydeco
July 31, 2017 – The U.S. FDA has approved an expanded indication for Kalydeco® (ivacaftor), manufactured by Vertex, to treat cystic-fibrosis patients two years of age and older who have any of five additional mutations that cause splicing defects in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Recommended dosage for patients six years of age and older is one 159mg tablet per day. Smaller doses of powdered Kalydeco mixed into soft foods should be used for patients younger than six years old. Originally approved in 2012 for the treatment of cystic fibrosis in patients with one of 23 other specific mutations, Kalydeco can now be used to treat an estimated additional 600 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 1-800-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.