Glaxo JV submits new drug application for shingles vaccine in Japan

GlaxoSmithKline’s joint venture with Daiichi Sankyo Co, Japan Vaccine Co., has submitted a new drug application in Japan seeking approval for the shingles vaccine, Shingrix.

The pharmaceuticals giant said the regulatory submission for the candidate vaccine is based on a comprehensive phase III clinical trial programme, evaluating its efficacy, safety and/or immunogenicity in more than 37,000 people in 18 countries, including Japan.

The phase III clinical trial programme showed that by reducing the incidence of shingles, the candidate vaccine also reduced the overall incidence of postherpetic neuralgia (PHN), which is a form of chronic pain associated with shingles.

Dr Emmanuel Hanon, senior vice president and head of Vaccines R&D at Glaxo, said: "Shingles is a common and often very unpleasant condition that can cause lasting pain and other serious complications such as scarring or visual impairment, which can severely impact the quality of people's lives.

"The probability of developing shingles increases with age and it is estimated that up to one in every three people will develop shingles in their lifetime. GSK's shingles candidate vaccine has been shown in phase III trials to help prevent shingles in older people, addressing the challenge of decreasing immunity that comes with age."

The submission to Japan’s regulatory authorities follows regulatory submissions to the US Food and Drug Administration in October last year and to Canadian regulatory authorities and the European Medicines Agency in November 2016.

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