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Drug news

Shingrix vaccine for herpes zoster filed with EMA- GlaxoSmithKline

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Last updated:27th Nov 2016

Published:27th Nov 2016

Source: Pharmawand

GlaxoSmithKline announced the regulatory submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for its candidate shingles vaccine, Shingrix, for the prevention of herpes zoster (shingles) in people aged 50 years or over.

The regulatory submission for the candidate vaccine is based on a comprehensive phase III clinical trial programme evaluating its efficacy, safety and immunogenicity in more than 37,000 people. This includes the ZOE-50 and ZOE-70 studies published in the New England Journal of Medicine in April 2015 and September 2016, respectively.

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