Vertex Pharmaceuticals (VRTX -4.3%) continues to expand the reach of cystic fibrosis (CF) med ORKAMBI (lumacaftor/ivacaftor). Today, it announced that Australia's Therapeutic Goods Administration approved it for the treatment of CF patients at least 12 years old who have two copies of the F508del mutation. There are ~1,000 patients there with the appropriate genetic profile.
The establishment of reimbursement is in process.
Health Canada cleared ORKAMBI in January. It was cleared in the EU in November 2015 and in the U.S. in July 2015.
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