TIDMGSK
RNS Number : 2614N
GlaxoSmithKline PLC
24 October 2016
Issued: 24 October 2016, London UK - LSE Announcement
GSK announces US regulatory submission of candidate vaccine for
prevention of shingles
- Regulatory submissions in the EU and Canada remain on track
for 2016
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has
submitted a Biologics License Application (BLA) for its candidate
shingles vaccine, Shingrix(TM) , 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.(1,2)
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.
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:
-- 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 Shingrix
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, AS01(B) , which is
intended to enhance the immunological response to the antigen(3) .
GSK intends to register the product as Shingrix(TM) , subject to
approval by relevant regulatory review bodies. The name Shingrix
has been approved by the European Medicines Agency.
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)
References
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(R) 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.
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. For further information please visit www.gsk.com.
GSK enquiries:
UK Media enquiries: David Mawdsley +44 (0) 20 8047 (London)
5502
Catherine Hartley +44 (0) 20 8047 (London)
5502
Melinda Stubbee +44 (0) 20 8047 (London)
5502
US Media enquiries: Sarah Alspach +1 202 715 1048
(Washington,
DC)
Sarah Spencer +1 215 751 3335 (Philadelphia)
Mary Anne Rhyne +1 919 483 0492 (North Carolina)
Karen Hagens +1 919 483 2863 (North Carolina)
Gwynne Oosterbaan +1 215 751 7468 (Philadelphia)
Analyst/Investor Tom Curry + 1 215 751 5419 (Philadelphia)
enquiries:
Gary Davies +44 (0) 20 8047 (London)
5503
James Dodwell +44 (0) 20 8047 (London)
2406
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements
or projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Such factors
include, but are not limited to, those described under Item
3.D 'Risk factors' in the company's Annual Report on Form 20-F
for 2015.
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END
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