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June 4, 2014
08:01 EDTVRTXVertex reports improvement in lung function in proof-of-concept ivacaftor study
Vertex Pharmaceuticals announced the results of a two-part proof-of-concept study of ivacaftor in 24 people with cystic fibrosis who have a residual function mutation. The first part of the study evaluated ivacaftor, compared with placebo, in a two-week crossover design over two treatment cycles, and the second part of the study evaluated ivacaftor in an eight-week open-label design. In part one, a statistically significant improvement in mean absolute lung function was observed after treatment with ivacaftor for two weeks compared with placebo. In part two of the study, improvements in lung function were observed after eight weeks of treatment. In the study, ivacaftor was generally well-tolerated, and the most common adverse events in the treatment group were cough and respiratory tract infection. This proof-of-concept study was the first to evaluate the use of ivacaftor in multiple residual function mutations and is supported by in vitro observations that showed ivacaftor enhanced the function of the cystic fibrosis transmembrane conductance regulator protein in cells with residual function mutations. Based on these data, Vertex plans to initiate a larger Phase 3 study in people with residual function mutations that will evaluate longer-duration treatment with ivacaftor, pending discussions with regulatory authorities.
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July 31, 2014
16:42 EDTVRTXVertex receives European approval for KALYDECO in eight gating mutations
Vertex Pharmaceuticals announced that the European Commission has approved KALYDECO for people with cystic fibrosis ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator gene. KALYDECO was first approved in Europe in July 2012 for people with CF ages 6 and older who have the G551D mutation, which is the most common gating mutation. The eight additional gating mutations included in today’s approval are G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D. In Europe, approximately 250 people ages 6 and older have one of these non-G551D gating mutations.
July 29, 2014
16:23 EDTVRTXVertex reports Q2 EPS (68c), consensus (72c)
Reports Q2 revenue $138M, consensus $132.06M.
15:53 EDTVRTXNotable companies reporting after market close
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