FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
Report of Foreign Issuer
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For
period ending 23 March
2018
GlaxoSmithKline plc
(Name
of registrant)
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address
of principal executive offices)
Indicate
by check mark whether the registrant files or
will
file annual reports under cover Form 20-F or Form 40-F
Form
20-F x Form 40-F
--
Indicate
by check mark whether the registrant by furnishing the
information
contained in this Form is also thereby furnishing the
information
to the Commission pursuant to Rule 12g3-2(b) under the
Securities
Exchange Act of 1934.
Yes
No x
Issued:
23 March 2018, London UK
Shingrix approved in Europe and Japan for the prevention of
shingles in adults aged 50 and over
●
The only shingles
vaccine to achieve ≥90% efficacy across all age groups
studied*
GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the
European Commission has approved Shingrix for the prevention of
shingles (herpes zoster) and post-herpetic neuralgia (PHN) in
adults aged 50 years or older.[i] The Japanese
Ministry of Health, Labour and Welfare (MHLW) has also
approved Shingrix for the prevention
of shingles (herpes zoster) in adults aged 50 years or older.
Shingrix is a non-live, recombinant subunit adjuvanted vaccine
given intramuscularly in two doses. In Japan, the vaccine is
registered to the Japan Vaccine Co., Ltd., a joint venture of
GlaxoSmithKline and Daiichi Sankyo Co., Ltd.
Shingles
is caused by reactivation of the varicella zoster virus, the same
virus that causes chickenpox. Nearly all adults over 50 have the
shingles virus dormant in their nervous system, waiting to
reactivate with advancing age.[ii]
Dr.
Thomas Breuer, Senior Vice President and Chief Medical Officer of
GSK Vaccines said: "The approvals of Shingrix in Europe and Japan
are recognition of the significant scientific advance this vaccine
represents. It has shown over 90% efficacy across all age groups
studied for the prevention of shingles, a painful and potentially
serious disease that affects around one in three
people.
"The
risk and severity of shingles increases with age as the immune
system loses the ability to mount a strong and effective response
to infection. Shingrix was developed specifically to overcome this
decline and to help protect people over 50 as we get older," he
said.
Shingrix
is the first approved shingles vaccine to combine a non-live
antigen, to trigger a targeted immune response, with a specifically
designed adjuvant to generate a strong and sustained immune
response.
Approval
of Shingrix follows a comprehensive Phase III clinical trial
program evaluating its efficacy, safety and immunogenicity in more
than 38,000 people. In a pooled analysis of the pivotal efficacy
studies, ZOE-50 and ZOE-70, Shingrix demonstrated efficacy against
shingles greater than 90% across all age groups studied, as well as
sustained efficacy over a follow-up period of 4 years.[iii],[iv] By preventing
shingles, Shingrix also reduced the overall incidence of
postherpetic neuralgia (PHN), a form of chronic nerve pain and the
most common complication associated with shingles. The most
common local side effects reported in the clinical trials were
pain, redness and swelling at the injection site. The majority were
mild to moderate in intensity and transient, generally lasting less
than three days.[v] [vi]
Shingrix
was approved in the US[vii] and
Canada[viii] in October 2017
and has been recommended by the US Centers for Disease Control and
Prevention's Advisory Committee on Immunization Practices as the
preferred vaccine for the prevention of herpes zoster and related
complications for immunocompetent adults aged 50 years and
older.[ix]
About Shingles
Shingles
is caused by the reactivation of the varicella zoster virus (VZV),
the same virus that causes chickenpox. Nearly all older adults have
the VZV dormant in their nervous system, waiting to reactivate with
advancing age.[x] As people age, the cells in the immune system
lose the ability to maintain a strong and effective response to VZV
reactivation.[xi]
Shingles
typically presents as a painful, itchy rash that develops on one
side of the body and can last for two to four weeks. The pain
associated with shingles is often described as burning, shooting or
stabbing.[xii] Even once the rash is gone, a person can experience
post-herpetic neuralgia (PHN), pain lasting from at least three
months up to several years. PHN is the most common complication of
shingles, occurring in up to 30 percent of all shingles cases.
[xiii]
Shingles
affects approximately 1.7 million Europeans annually[xiv] -
approximately 600,000 new cases are reported in Japan each
year.[xv]
Older adults and those with conditions that compromise the immune
system have the greatest risk for developing shingles. More than 99
percent of those over 50 years old are infected with VZV and, it is
estimated that around one in three people will develop shingles in
their lifetime.[xvi]
About Shingrix
Shingrix
[Herpes Zoster vaccine (non-live recombinant, AS01B adjuvanted)] is a
non-live, recombinant subunit vaccine to help prevent shingles
(herpes zoster) in adults 50 years of age and older. The vaccine
combines an antigen, glycoprotein E, and an adjuvant system,
AS01B,
intended to generate a strong and long-lasting immune response that
can help overcome the decline in immunity that occurs as people
age.[xvii]
[xviii]i
Shingrix
is to be given intramuscularly in two doses.
Important Safety Information for Shingrix
●
You should
not receive Shingrix if you are allergic to any of its ingredients
or had an allergic reaction to a previous dose of
Shingrix.
●
The most
common side effects are pain, redness, and swelling at the
injection site, muscle pain, tiredness, headache, shivering, fever,
and upset stomach.
●
Vaccination with Shingrix may not protect all
individuals.
Shingrix is not indicated for the prevention of
chickenpox.
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:
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Global
Media enquiries:
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Simon
Steel
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+44 (0)
20 8047 5502
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(London)
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Simon
Moore
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+44 (0)
20 8047 5502
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(London)
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US
Media enquiries:
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Sarah
Spencer
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+1 215
751 3335
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(Philadelphia)
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Gwynne
Oosterbaan
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+1 215
751 7468
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(Philadelphia)
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Analyst/Investor
enquiries:
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Sarah
Elton-Farr
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+44 (0)
20 8047 5194
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(London)
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Tom
Curry
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+ 1 215
751 5419
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(Philadelphia)
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Gary
Davies
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+44 (0)
20 8047 5503
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(London)
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James
Dodwell
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+44 (0)
20 8047 2406
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Cautionary statement regarding forward-looking statementsGSK
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
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2017.
.
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Registered in England & Wales:
No. 3888792
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Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
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* non
immune-compromised subjects
[i] http://ec.europa.eu/health/documents/community-register/index_en.htm
[ii] Harpaz R,
Ortega-Sanchez IR, Seward JF; Advisory Committee on Immunization
Practices (ACIP), Centers for Disease Control and Prevention (CDC).
Prevention of herpes zoster: recommendations of the Advisory
Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2008
Jun;57(RR-5):1-30
[iii] Lal H et al. Efficacy of an Adjuvanted
Herpes Zoster Subunit Vaccine in Older Adults. N Engl J Med.
2015;372:2087-96.
[iv] Cunningham et al.
Efficacy of the herpes zoster subunit vaccine in adults 70 years of
age or older. N Engl J Med.
2016;375:1019-32.
[v] GlaxoSmithKline. Data on File. 2017.
[vi] Lal H, et al., 2015.
[vii] https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf
[viii] https://ca.gsk.com/media/1350788/shingrix_pm-2017-10-13.pdf
[ix] https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm
[x] Harpaz et
al. 2008
[xi] Harpaz et al. 2008;
Johnson RW et al. Herpes zoster epidemiology, management, and
disease and economic burden in Europe: a multidisciplinary
perspective. Therapeutic Advances in
Vaccines. 2015;3(4):109-120.
[xii] Harpaz et al. 2008; Robert W Johnson & Tessa
L Whitton (2005) Management of herpes zoster (shingles) and
postherpetic neuralgia, Expert Opinion on Pharmacotherapy, 5:3,
551-559.
[xiii] Kawei K et al., BMJ Open
2014;4(6):e004833
[xiv] Pinchinat et al. Similar herpes zoster incidence
across Europe: results from a systematic literature review. BMC
Infectious Diseases 2013,
13:170
[xv] Gnann et al. Clinical practice. Herpes zoster.
N Eng J Med.
2002;347(5):340-6.
[xvi] Harpaz et al. 2008; Brissson et al. Epidemiology
of varicella zoster virus infection in Canada and the United
Kingdom. Epidemiol.
Infect. (2001), 127,
305±314.
[xvii] Lal H, et al., 2015.; Garçon N, et al.
Understanding modern vaccines. 2011.
[xviii]i 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.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GlaxoSmithKline plc
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(Registrant)
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Date: March
23, 2018
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By: VICTORIA
WHYTE
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GlaxoSmithKline plc
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