GlaxoSmithKline applies for European approval of new shingles vaccine

GlaxoSmithKline has applied for European regulatory approval of Shingrix, a new candidate vaccine for the prevention of shingles.

A marketing authorisation application has been filed with the European Medicines Agency seeking approval for Shingrix as a means of preventing shingles, also known as herpes zoster, in people aged 50 years or over.

Data from a phase III clinical trial programme involving more than 3,700 people showed that by reducing the incidence of shingles, the vaccine is able to reduce the overall incidence of postherpetic neuralgia, a form of chronic pain associated with the condition.

The vaccine is designed to be given intramuscularly in two doses, with a two to six-month interval between doses. Regulatory submissions have also been filed in the US and Canada.

Dr Emmanuel Hanon, senior vice-president and head of vaccines research and development at GlaxoSmithKline, said: "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."

The company will also be seeking approval for the vaccine from Japanese regulators in 2017.

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