Blueprint
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
October 2017
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:
20 October 2017, London UK
Shingrix approved in the US for prevention of shingles in adults
aged 50 and over
Pooled clinical trial results showed > 90 percent
efficacy across all age groups
GlaxoSmithKline
plc [LSE/NYSE: GSK] today announced that the US Food and Drug
Administration (FDA) has approved Shingrix (Zoster Vaccine
Recombinant, Adjuvanted) for the prevention of shingles (herpes
zoster) in adults aged 50 years and older. Shingrix is a
non-live, recombinant subunit vaccine given intramuscularly in two
doses.
Dr.
Thomas Breuer, Senior Vice President and Chief Medical Officer of
GSK Vaccines said: "Shingrix represents a significant scientific
advancement in the field of vaccinology. The vaccine has shown over
90% efficacy across all age groups in the prevention of shingles, a
painful and potentially serious disease that affects 1 in 3 people
in the United States.1 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 the age-related
decline in immunity."
Approval
of Shingrix is based on a comprehensive Phase III clinical trial
program evaluating its efficacy, safety and immunogenicity in more
than 38,000 people. In a pooled analysis of these studies, Shingrix
demonstrated efficacy against shingles greater than 90% across all
age groups, as well as sustained efficacy over a follow-up period
of 4 years.2,3 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.
Luc
Debruyne, President of Global Vaccines at GSK said: "We believe
Shingrix will provide confidence in the protection one can expect
from a shingles vaccine. GSK is committed to partnering with the
public health and medical community to help address the gaps in
vaccine coverage among adults that persist in the United
States."
The US
Centers for Disease Control and Prevention's Advisory Committee on
Immunization Practices (ACIP) is expected to vote on a
recommendation for the use of Shingrix at its meeting on 25 October
2017.
Following
this approval from FDA, and pending a recommendation from ACIP,
Shingrix will be available shortly.
On 13
October 2017, Shingrix was approved in Canada for the prevention of
shingles (herpes zoster) in people aged 50 years or older.
Regulatory filings in the European Union, Australia and Japan are
underway.
About shingles
Shingles is caused by the reactivation of the varicella zoster
virus (VZV), the same virus that causes
chickenpox.1 Nearly all older adults have the VZV dormant in
their nervous system, waiting to reactivate with advancing
age.4 As people age, the cells in the immune system
lose the ability to maintain a strong and effective response to VZV
reactivation.1,5,
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. 2,5 Even once the rash is gone, a person can
experience postherpetic neuralgia (PHN), pain lasting from at least
three months up to several years.1 PHN is the most common complication of
shingles, occurring in 10 to 18 percent of all shingles
cases.1,6,
There are an estimated 1 million cases of shingles in the United
States each year.1 More than 99 percent of those over 50
years old are infected with VZV, and one in three Americans will
develop shingles in their lifetime. The risk increases to one in
two for adults aged 85 years and older.1,7,
About Shingrix
Shingrix
is a non-live, recombinant subunit vaccine approved in the United
States and Canada to help prevent shingles (herpes zoster) in
people aged 50 years or older. It 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 as people age.8
Full US Prescribing Information will be available soon at
www.us.gsk.com.
Prior to the label being posted online, a copy of the label may be
requested from one of the GSK Media or Investor Relations contacts
listed in the "GSK Enquiries" section at the end of this
document.
Shingrix Important Safety Information
●
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.
●
Ask your healthcare provider
about the risks and benefits of SHINGRIX. Only a healthcare
provider can decide if SHINGRIX is right for you.
SHINGRIX
is not indicated for the prevention of chickenpox.
Inside Information
The
information contained in this announcement is inside
information.
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.
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GSK enquiries:
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UK
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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David
Daley
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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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Sean
Clements
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+1 215
347 9274
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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 2016.
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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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1 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.
2 Lal H et al. Efficacy
of an Adjuvanted Herpes Zoster Subunit Vaccine in Older
Adults. N
Engl J Med. 2015;372:2087-96.
3 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.
4 Gnann et al. Clinical
practice. Herpes zoster. N Eng J Med.
2002;347(5):340-6.
5 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.
6 Yawn et al. Health care
utilization and cost burden of herpes zoster in a community
population. Mayo Clin Proc.
2009;84(9):787-94.
7 Cohen et al. Herpes
Zoster. N
Eng J Med. 2013;369:255-63.
8 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: October
23, 2017
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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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