Glaxo's Shingles Vaccine Shingrix Gets FDA Panel Backing
14 September 2017 - 5:10PM
Dow Jones News
By Razak Musah Baba
LONDON-GlaxoSmithKline PLC's (GSK.LN) shingles vaccine Shingrix,
or HZ/su, has been approved for adults aged 50 and over by the U.S.
Food and Drug Administration's Advisory Committee.
The pharmaceutical company said Thursday that the FDA's vaccines
and related biological products advisory committee, or VRBPAC,
voted unanimously that the data support the efficacy and safety of
Shingrix for the prevention of herpes zoster or shingles.
The FDA Advisory Committees provide nonbinding recommendations
for consideration by the FDA, with the final decision on approval
made by the FDA, GSK said.
"Thursday's vote brings us one step closer to approval of
Shingrix, which is specifically designed to overcome age-related
weakening of the immune system," said Dr. Emmanuel Hanon, senior
vice president and head of vaccines research and development.
GSK's shingles candidate vaccine is not currently approved for
use anywhere in the world. Regulatory filings in the European
Union, Canada, Australia and Japan are underway.
Write to Razak Musah Baba at razak.baba@wsj.com; Twitter:
@Raztweet
(END) Dow Jones Newswires
September 14, 2017 02:55 ET (06:55 GMT)
Copyright (c) 2017 Dow Jones & Company, Inc.
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