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 14 September
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: 13 September 2017, London UK
FDA Advisory Committee votes unanimously for
Shingrix (HZ/su) in the US for prevention of herpes
zoster (shingles) in adults ages 50 and over
GlaxoSmithKline plc [LSE/NYSE: GSK] announced today that the
Vaccines and Related Biological Products Advisory Committee
(VRBPAC) of the US Food and Drug Administration (FDA) voted
unanimously that the data support the efficacy and safety of
Shingrix for the prevention of herpes zoster (shingles) in adults
ages 50 and over. FDA Advisory Committees provide non-binding
recommendations for consideration by the FDA, with the final
decision on approval made by the FDA.
Dr. Emmanuel Hanon, Senior Vice President and Head of Vaccines
R&D for GSK said: "Shingles is a painful
and potentially serious condition. The risk of developing shingles
increases with age and it is estimated
that up to one in three people in the United States will develop
shingles. Today's vote brings
us one step closer to approval of Shingrix, which is specifically
designed to overcome age-related weakening of the immune
system."
The Biologics License Application (BLA) was submitted to the FDA in
October 2016.
GSK's shingles candidate vaccine is not currently approved for use
anywhere in the world. Regulatory filings in the European Union,
Canada, Australia and Japan are underway.
About the candidate vaccine
The candidate vaccine is a non-live, recombinant subunit vaccine to
help prevent herpes zoster (shingles)
and its complications, such as postherpetic neuralgia, in adults 50
years of age and older. The candidate 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 as people age.1 The name "Shingrix" has not yet been approved for
use by any regulatory authority.
About shingles
Shingles is caused by varicella zoster virus (VZV), the same virus
that causes chickenpox.2 Nearly all older adults have the VZV dormant
in their nervous system, waiting to reactivate with advancing
age.3 As people age, the cells in the immune
system lose the ability to mount a strong and effective response to
infection.4 Shingles
typically presents as a rash, with painful blisters across the
chest, abdomen or face. The pain
is often described as aching, burning, stabbing or shock-like.
Following the rash, a person can also
experience postherpetic neuralgia (PHN), pain lasting from at least
three months up to several years.2 PHN is the most common complication of shingles,
occurring in up to 30 percent of all shingles
cases.5
There are an estimated 1 million cases of shingles in the United
States each year.2 Incidence rates are similar throughout North America, Europe and
Asia-Pacific regions.5 Older adults and those with
conditions
that compromise the immune system have the greatest risk for
developing shingles. More than
99.5 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.2,6
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:
Simon
Steel
+44 (0) 20 8047 5502 (London)
David
Daley +44
(0) 20 8047 5502 (London)
US Media enquiries:
Sarah
Spencer
+1 215 751 3335 (Philadelphia)
Gwynne Oosterbaan
+1 215 751 7468 (Philadelphia)
Sean
Clements
+1 215 347 9274 (Philadelphia)
Analyst/Investor enquiries:
Sarah Elton-Farr
+44 (0) 20 8047 5194 (London)
Tom Curry
+ 1 215 751 5419 (Philadelphia)
Gary Davies
+44 (0) 20 8047 5503 (London)
James Dodwell
+44 (0) 20 8047 2406 (London)
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
'Principal risks and uncertainties' in the company's Annual Report
on Form 20-F for 2016.
Registered in England & Wales:
No. 3888792
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
1 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.
2 Harpaz, et
al. MMWR Recomm
Rep.2008;
57(5): 1-30. Prevention of herpes zoster: recommendations of
the Advisory Committee on
Immunization Practices.
3 Gnann, et
al. N Eng J
Med.2002;
347(5): 340-6. Clinical practice. Herpes
zoster.
4 Gruver, et
al. J
Pathol.2007:
211(2): 144-56. Immunosenescence of ageing.
5 Kawai, et
al. BMJ
Open.2014;
4(6). Systematic review of incidence and complications of herpes
zoster: towards a global perspective.
6 Cohen, et
al. N Eng J
Med. 2013; 369: 255-263. Herpes
Zoster.
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: September
14, 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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