GSK announces EU regulatory submission of candidate vaccine for prevention of shingles—follows regulatory submissions in U.S. and Canada.
GlaxoSmithKline plc announced the regulatory submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval for its 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, recombinant vaccine to help prevent shingles and its complications. The phase III clinical trial program 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 program 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 program. 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 U.S. 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.
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 antigen3. GSK intends to register the product as Shingrix, subject to approval by relevant regulatory review bodies.
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 U.S.; 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 localized 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
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.
(Source: GlaxoSmithKline plc)