GlaxoSmithKline plc has submitted a Biologics License Application (BLA) for its candidate shingles vaccine, Shingrix, to the United States Food and Drug Administration (FDA), seeking approval for the prevention of herpes zoster (shingles) in people aged 50 years or over.
The candidate vaccine is a non-live, recombinant vaccine to help prevent shingles and its complications. 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, with a two to six month interval between doses.
Dr Emmanuel Hanon, senior vice president and head of Vaccines R&D, GSK said, “Shingles is a common and potentially serious condition. It can cause lasting pain and other complications such as scarring or visual impairment, which can severely impact the quality of people’s lives. The risk of developing shingles increases with age and it is estimated that up to one in every three people is at risk. 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 regulatory submission for Shingrix is based on a comprehensive phase III clinical trial programme evaluating its efficacy, safety and immunogenicity in more than 37,000 people. This includes the ZOE-50 and ZOE-70 studies published in the New England Journal of Medicine in April 2015 and September 2016, respectively. The candidate vaccine is one of the more than 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.
Regulatory submissions in the European Union and Canada are on track for 2016 and planned for Japan in 2017. GSK’s shingles candidate vaccine 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 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:
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.
