Kalydeco Approved for Young Children
March 10, 2015 – The U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor), manufactured by Vertex. Kalydeco is now approved for use in children ages two to five with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R and R117H). According to Vertex, there are approximately 300 children in the U.S. ages two to five years with these mutations. Previously, Kalydeco was approved for patients six years of age and older with these mutations. The FDA also approved a new oral granule formulation of Kalydeco packaged in 50mg and 75mg packets and which can be mixed in soft foods and liquids.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.