Vertex Pharmaceutical Incorporated announced that the Therapeutic Goods Administration (TGA) of Australia has approved ORKAMBI® 200/125 (lumacaftor 200mg and ivacaftor 125mg), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older who have two copies of the F508del mutation. In Australia, there are approximately 1,000 people with CF ages 12 and older who have two copies of this mutation. The Australian reimbursement process for ORKAMBI is already underway as part of the parallel regulatory and reimbursement processes between the TGA and the Pharmaceutical Benefits Advisory Committee (PBAC).