GSK Announces EU Regulatory Submission of Candidate Vaccine for Prevention of Shingles

GlaxoSmithKlineGlaxoSmithKline plc (LSE/NYSE: GSK) has announced the regulatory submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval for its candidate shingles vaccine, ShingrixTM, 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.

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.1,2

Dr Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D, GSK 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.

About the phase III study programme
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.(1)
  • 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.(2)

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.

About the candidate vaccine
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 varicella zoster virus (VZV) that causes shingles, with an adjuvant system, AS01B, which is intended to enhance the immunological response to the antigen(3). GSK intends to register the product as ShingrixTM, subject to approval by relevant regulatory review bodies.

About shingles
Shingles typically presents as a painful, itchy rash that develops on one side of the body, as a result of reactivation of latent chickenpox virus (varicella zoster virus or VZV). Data from many countries indicates that more than 90% of adults have been infected with varicella during childhood. The individual lifetime risk of developing shingles is approximately one in three for people in the USA; however, this increases to one in two people aged 85 and over. A person's risk for shingles increases sharply after 50 years of age due to a natural age-related decline in immune system function, or as a consequence of an underlying immunocompromising condition.(4)

The most common complication from shingles is post-herpetic neuralgia, defined as a localised pain of significant intensity persisting at least 90 days after the appearance of the acute shingles rash. Other complications of shingles include ophthalmologic, neurological and cutaneous disease, which can result in severe disability.5

About GSK
GSK - one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

1. Lal et al., N Engl J Med 2015; 372:2087-2096 Efficacy of an Adjuvanted Herpes Zoster Subunit Vaccine in Older Adults.
2. Cunningham et al., N Engl J Med 2016; 375: 1019-32. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older.
3. The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics LLC, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.
4. Shingles (Herpes Zoster) Clinical Overview. US Centers for Disease Control and Prevention. Accessed at: http://www.cdc.gov/shingles/hcp/clinical-overview.html on 6 Sept 2016.
5. Cohen et al., N Engl J Med 2013;369:255-63 Clinical practice: Herpes zoster.

Most Popular Now

SK bioscience and GSK start Phase 3 trial of adjuv…

SK bioscience (SK) and GlaxoSmithKline plc (GSK) today announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination wit...

No serious health effects linked to mRNA COVID-19 …

Federal and Kaiser Permanente researchers combing the health records of 6.2 million patients found no serious health effects that could be linked to the 2 mRNA COVID-19 v...

Blood vessels produce growth factor that promotes …

Blood vessels supply tumors with nutrients and, on the other hand, enable cancer cells to spread throughout the body. The settlement of circulating tumor cells in a dista...

First-in-human clinical trial for a vaccine to tre…

The first patients have been enrolled in a phase 1 randomized placebo-controlled clinical trial to study a therapeutic vaccine for opioid use disorder developed by resear...

Sandoz strengthens pipeline by entering into agree…

Sandoz, a Novartis division, today announced that it has entered into a commercialization agreement with Bio-Thera Solutions, Ltd. for biosimilar bevacizumab (BAT1706). B...

Pfizer and BioNTech submit a variation to EMA with…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced that they submitted a variation to the European Medicines Agency (EMA) requesting to update the Condition...

A drug costing less than €2 a day helps in the tre…

Metoprolol, a drug widely used to treat cardiovascular disease, is beneficial when administered to COVID-19patients. This is the finding of a study by investigators at th...

Rheumatoid arthritis treated with implanted cells …

With a goal of developing rheumatoid arthritis therapies with minimal side effects, researchers at Washington University School of Medicine in St. Louis have genetically ...

NIH scientists build a cellular blueprint of multi…

Chronic lesions with inflamed rims, or "smoldering" plaques, in the brains of people with multiple sclerosis (MS) have been linked to more aggressive and disabling forms ...

Scientific evidence to date on COVID-19 vaccine ef…

An expert review by an international group of scientists, including some at the WHO and FDA, concludes that, even for the delta variant, vaccine efficacy against severe C...

How a plant virus could protect and save your lung…

Using a virus that grows in black-eyed pea plants, nanoengineers at the University of California San Diego developed a new treatment that could keep metastatic cancers at...

COVID-19 nasal vaccine candidate effective at prev…

Breathe in, breathe out. That’s how easy it is for SARS-CoV-2, the virus that causes COVID-19, to enter your nose. And though remarkable progress has been made in develop...