Orkambi Approved for Cystic Fibrosis
July 2, 2015 – The U.S. Food and Drug Administration (FDA) approved Vertex Pharmaceutical’s Orkambi (lumacaftor/ivacaftor). Orkambi is indicated the treatment of people with cystic fibrosis (CF) who are ages 12 years and older, who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. To utilize Orkambi as indicated, patients must have been identified with a genetic test. Orkambi is to be taken orally every 12 hours at a recommended dose of two tablets with each containing lumacaftor 200mg/ivacaftor 125mg). Orkambi is anticipated to cost about $259,000 per year and will be available through limited distribution.
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
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.