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.
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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.
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(END) Dow Jones Newswires
September 14, 2017 02:55 ET (06:55 GMT)