Vertex Orkambi's Label Expanded In U.S., Outlook Revised
Zacks Investment Research | Sep 29, 2016 10:40PM ET
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) announced that its cystic fibrosis (CF) drug, Orkambi, was approved in the U.S. for the treatment of CF in patients aged 6–11 years who have two copies of the F508del mutation. The company said that the drug will be available to the eligible population shortly.
Vertex also plans to file a Marketing Authorization Application (MAA) variation in the EU for the same indication in the first half of 2017.
Note that Orkambi is a combination of lumacaftor and Kalydeco (ivacaftor), a marketed CF drug in the company’s portfolio. Orkambi was approved in the U.S. and the EU in Jul 2015 and Nov 2015, respectively, for the treatment of CF in patients aged 12 years and older, who have two copies of the F508del mutation in their CF transmembrane conductance regulator (CFTR) gene. In the first six months of 2016, Orkambi raked in sales of $468.7 million.
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