Japan Vaccine Co Seeks Japanese Approval for Shingrix

GSK announced that Japan Vaccine Co., Ltd., a joint venture of GlaxoSmithKline and Daiichi Sankyo Co., Ltd., submitted a New Drug Application in Japan seeking approval for the candidate shingles vaccine, Shingrix, for the prevention of herpes zoster (shingles) in people aged 50 years or over. The candidate vaccine is a non-live, subunit vaccine developed to help prevent shingles and its complications.

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), a form of chronic pain associated with shingles. Regulatory approval is being sought for the vaccine to be given intramuscularly in two doses.

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

The candidate shingles vaccine, Shingrix, is one of the ~40 assets profiled to investors at GSK's R&D event in November 2015 and belongs to the company's vaccines portfolio - one of six core areas of scientific research and development alongside oncology, immunoinflammation, and infectious, respiratory and rare diseases. Shingrix is not currently approved for use anywhere in the world.