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.
Dr Emmanuel Hanon, senior vice president and head of vaccines R&D, GSK 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.”
Shinichi Terano, president and representative director, Japan Vaccine Co., Ltd. said: “Today’s file submission puts us a step closer to making this vaccine available to help protect more people in Japan from shingles and the complications associated with it.”
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, immuno-inflammation, and infectious, respiratory and rare diseases. Shingrix is not currently approved for use anywhere in the world.
Involving more than 37,000 subjects globally, the phase III programme evaluated the efficacy, safety and/or immunogenicity of two doses of GSK’s candidate shingles vaccine given intramuscularly two months apart in older adults. Data from all the completed studies has been included in the regulatory file, including: The ZOE-50 (ZOster Efficacy in adults aged 50 years and over) (NCT01165177) trial of 16,160 adults aged 50 years and older studied overall vaccine efficacy against shingles compared to placebo. The data were published in April 2015 in the NEJM: The ZOE-70 (ZOster Efficacy in adults aged 70 years and over) (NCT01165229) trial of more than 14,800 adults aged 70 years and older studied overall vaccine efficacy against shingles compared to placebo. Additionally, a pooled analysis of data from the ZOE-70 and ZOE-50 trials assessed overall vaccine efficacy in reducing the risk of developing shingles and PHN in people aged 70 years and over. These data were published in September 2016 in the NEJM.
A clinical study is also underway to evaluate revaccination in subjects who have previously been vaccinated against shingles with a live-attenuated vaccine. Additional trials include solid tumor and haematological cancer patients, haematopoietic stem cell and renal transplant recipients and HIV-infected people. These studies will provide additional information on the candidate vaccine’s safety and ability to stimulate immune responses in populations at high risk of shingles because of the weakening of their immune system.
The candidate vaccine is a non-live, recombinant vaccine to help prevent herpes zoster and its complications and combines glycoprotein E, a protein found on the surface of varicella zoster virus (VZV), with an adjuvant system, AS01B, which is intended to enhance the immunological response to the antigen. GSK intends to register the product as Shingrix, subject to approval by relevant regulatory review bodies. In Japan the JVC will register the product.