LONDON (dpa-AFX) - GlaxoSmithKline plc (GSK, GSK.L) announced it has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, Shingrix, to the U.S. FDA, seeking approval for the prevention of herpes zoster (shingles) in people aged 50 years or over. The regulatory submission is based on a phase III clinical trial programme evaluating efficacy, safety and immunogenicity of Shingrix in more than 37,000 people.
GSK said regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017.
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