Vertex Pharmaceuticals (MA) Release: The New England Journal of Medicine Publishes Data from Phase 3 STRIVE Study of KALYDECOTM (ivacaftor) in People Ages 12 and Older with a Specific Type of Cystic Fibrosis

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq:VRTX) today announced that the New England Journal of Medicine (NEJM) published data from a Phase 3 study of KALYDECO™ (ivacaftor, VX-770), a medicine in development that targets the defective protein that causes cystic fibrosis (CF). In this study, called STRIVE, people with CF ages 12 and older with at least one copy of the G551D mutation who were treated with KALYDECO (kuh-LYE-deh-koh) experienced significant improvements in lung function and other measures of disease. Improvements in lung function (forced expiratory volume in one second, FEV1) were seen as early as week two and were sustained throughout the 48-week study. The most commonly reported adverse events were respiratory in nature and comparable across treatment groups. Data from STRIVE will be published along with an accompanying editorial in the November 3, 2011 issue of NEJM. Data from a second pivotal Phase 3 study, ENVISION, which evaluated KALYDECO in children with CF ages 6 to 11 years who had at least one copy of the G551D mutation, will be presented at the North American CF Conference, November 3-5, 2011 in Anaheim, Calif.
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