Vertex Wins U.S. Approval for Cystic Fibrosis Combo Orkambi
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Vertex Pharmaceuticals Inc. won U.S. approval for its combination treatment for the most common form of cystic fibrosis, giving the drugmaker what analysts have projected will be a new blockbuster.
The Food and Drug Administration cleared the medicine, called Orkambi, for sale for patients 12 and older who suffer from the deadly lung disease, according to a letter posted in an FDA database. Orkambi is a combination of a drug called Kalydeco that Vertex already sells for a smaller group of cystic fibrosis patients and another medicine called lumacaftor.