Vertex CF drugs win FDA's first breakthrough therapy designations

01/10/2013 | PharmaTimes (U.K.) · Bloomberg

The FDA awarded the first two breakthrough therapy designations to two cystic fibrosis drugs from Vertex Pharmaceuticals. The first designation was given to Kalydeco, or ivacaftor, for potential additional indications. The other designation was granted to a combination of Kalydeco and the experimental drug VX-809. The goal of the breakthrough therapy designation, which was enacted under the 2012 Food and Drug Administration Safety and Innovation Act, is to speed up the development and evaluation of new drugs for serious or life-threatening diseases.

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PharmaTimes (U.K.) · Bloomberg

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