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News Breaks | | | | January 6, 2013 | | 18:23 EDT |  | VRTX | Vertex announces FDA grants the first two 'Breakthrough Therapy Designations'
Vertex announced that the U.S. Food and Drug Administration, FDA, granted the first two Breakthrough Therapy Designations to ivacaftor monotherapy and the combination regimen of VX-809 with ivacaftor for CF. Enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act. FDASIA, Breakthrough Therapy Designation is intended to expedite the development and review of a potential new medicine if it is “intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”1 | |
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News For VRTX From The Last 14 Days Check below for free stories on VRTX the last two weeks. |
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