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www.fdanews.com/articles/173843-gsks-shingrix-shows-positive-results-in-phase-3-trial
GlaxoSmithKline (GSK)

GSK’s Shingrix Shows Positive Results in Phase 3 Trial

November 2, 2015

GlaxoSmithKline’s shingles vaccine Shingrix met its primary endpoint in a second pivotal Phase 3 trial, demonstrating 90 percent efficacy in adults 70 years of age and older, compared with placebo.

A pre-specified pooled analysis of the vaccine, known as ZOE-70, also demonstrated that it prevents subsequent chronic neuropathic pain, which is the most common severe complication of shingles.

GSK plans to submit a regulatory application for Shingrix for people 50 years of age and older in North America, Japan and the EU during the second half of 2016.