LONDON, Sept. 13, 2017 /PRNewswire/ -- 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
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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 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.
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SOURCE GSK