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news.GlaxoSmithKline (GSK) has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for its shingles vaccine candidate dubbed Shingrix, for herpes zoster (shingles) prevention in people aged 50 years or over.
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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.
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.
This includes the ZOE-50 and ZOE-70 studies published in the New England Journal of Medicine in April 2015 and September 2016, respectively.
GSK Vaccines R&D senior vice president and head Dr Emmanuel Hanon 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.”
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.
The submission to the EMA follows regulatory submissions to the US Food and Drug Administration (FDA) in October of this year and to Canada regulatory authorities earlier this month, with a Japan submission planned for 2017.
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, 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 the currently available live-attenuated vaccine. Additional trials are underway in solid 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.