LONDON (Alliance News) - Drugmaker GlaxoSmithKline PLC on Monday said its has submitted a biologics licence application for its Shingrix shingles vaccine in the US.
The submission is seeking approval from the US Food & Drug Administration for Shingrix to be used to treat shingles for people aged 50 or over.
Glaxo added the regulatory submissions for the drug in both the European Union and Canada are on track for 2016.
"The risk of developing shingles increases with age and it is estimated that up to one in every three people is at risk. Today's file submission puts us a step closer to making this vaccine available to help protect more people from shingles and the complications associated with it," said Emmanuel Hanon, senior vice-president and head of vaccines research and development at Glaxo.
By Sam Unsted; samunsted@alliancenews.com; @SamUAtAlliance
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Glaxosmithkline (GSK)