GlaxoSmithKline seeks European approval for shingles vaccine

GlaxoSmithKline announced the regulatory submission of a marketing authorisation application to the European Medicines Agency for approval of its candidate shingles vaccine, Shingrix.

The phase III clinical trial of the vaccine – for the prevention of shingles in people over 50 and its complications – showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia (PHN), a form of chronic pain associated with the condition.

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.

Dr Emmanuel Hanon, senior vice president and head of Vaccines Research & Development at Glaxo, said: “Shingles is a common but serious condition that results from the reactivation of the virus that causes chicken pox and can cause lasting pain and other complications. The probability of developing shingles increases with age and it is estimated that up to one in every three people will develop shingles during their life.

“GSK's shingles candidate vaccine has consistently shown high efficacy in older people in its phase III development programme. 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."

Regulatory submissions were made to the US Food and Drug Administration and to Canadian regulatory authorities in October and earlier this month, respectively. Glaxo plans on making a submission in Japan next year.

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