![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » GSK’s Shingrix Shows Positive Results in Phase 3 Trial
GSK’s Shingrix Shows Positive Results in Phase 3 Trial
![GlaxoSmithKline (GSK)](https://www.fdanews.com/ext/resources/test/Drug-Images/GSK.gif?t=1616695645&width=430)
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.
Upcoming Events
-
21Oct