TIDMGSK
RNS Number : 2625U
GlaxoSmithKline PLC
20 October 2017
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, AS01(B) , 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.
GSK enquiries:
UK Media enquiries: Simon Steel +44 (0) 20 (London)
8047 5502
David Daley +44 (0) 20 (London)
8047 5502
US Media enquiries: Sarah Spencer +1 215 751 (Philadelphia)
3335
Gwynne Oosterbaan +1 215 751 (Philadelphia)
7468
Sean Clements +1 215 347 (Philadelphia)
9274
Analyst/Investor Sarah Elton-Farr +44 (0) 20 (London)
enquiries: 8047 5194
Tom Curry + 1 215 751 (Philadelphia)
5419
Gary Davies +44 (0) 20 (London)
8047 5503
James Dodwell +44 (0) 20 (London)
8047 2406
Jeff McLaughlin +1 215 751 (Philadelphia)
7002
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:
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TW8 9GS
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(R) adjuvant licensed from Antigenics LLC, a wholly owned
subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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