LONDON, Oct. 20, 2017 /PRNewswire/
-- 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.
GSK
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David
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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.
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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.
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SOURCE GSK