Posted from: Tuesday, August 04, 2015 - 12:05 PM - Present

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.


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Last Updated Monday, September 16, 2019 - 08:06 AM.