Vertex's Third Cystic Fibrosis Treatment Gets FDA Approval
Zacks Investment Research | Feb 12, 2018 10:35PM ET
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) announced that the FDA has granted approval to its cystic fibrosis (CF) corrector, tezacaftor (VX-661), in combination with ivacaftor (Kalydeco) under the brand name, Symdekotm. The combo therapy is approved to treat the underlying cause of CF in patients aged 12 years and above with certain mutations in the CF transmembrane conductance regulator gene.
This approval marks the company's third treatment for the underlying cause of CF. The company said that it is ready to launch the product in the U.S. market this week. With this nod from the regulatory agency, Vertex can address a significantly larger CF patient population in the United States.
Notably, the combination regime is also under review in the EU with a decision expected in the second half of 2018.
Vertex’s share price has soared 73.2% in a year’s time, comparing favorably with the Zacks Investment Research
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