GlaxoSmithKline's Shingrix Gets Positive Opinion From US FDA Committee

LONDON (Alliance News) - GlaxoSmithKline PLC late Wednesday said a US Food & Drug Admiistration ...

Alliance News 14 September, 2017 | 7:01AM
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LONDON (Alliance News) - GlaxoSmithKline PLC late Wednesday said a US Food & Drug Admiistration advisory committee voted unanimously in favour of its shingles vaccine, Shingrix.

The Vaccines & Related Biological Products Advisory Committee voted unanimously that data support the efficacy and safety of Shingrix for the prevention of shingles in adults aged 50 and over.

This committee provides non-binding recommendations to be considered by the FDA, and the final decision is still pending from the FDA.

"Shingles is a painful and potentially serious condition. The risk of developing shingles increases with age and it is estimated that up to one in three people in the United States will develop shingles. Today’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 Emmanuel Hanon, head of Vaccines Research & Development for Glaxo.

Victrex is not currently approved for use anywhere in the world. Regulatory filings in the European Union, Canada, Australia and Japan are underway, the drugsmaker said.

By Hana Stewart-Smith; hanassmith@alliancenews.com; @HanaSSAllNews

Copyright 2017 Alliance News Limited. All Rights Reserved.

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Securities Mentioned in Article
Security Name Price Change (%) Morningstar Rating
GlaxoSmithKline PLC 1,470.00 GBX 1.10
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