REG - GSK PLC - GSK files Shingrix 18+ at risk indication in Japan

GSKAnnouncement

28/06/2022 07:00

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RNS Number : 3750Q  GSK PLC  28 June 2022

Issued: 28 June 2022, London UK

 

Japan's Ministry of Health, Labour and Welfare accepts Shingrix regulatory
submission to prevent shingles in at-risk adults aged 18 years and older

 

·   Regulatory submission aims to expand the number of people who can be
protected against shingles, including those with immunodeficiency or
immunosuppression

·   Shingrix is already approved in Japan for adults aged 50 years and
above

 

GSK plc (LSE/NYSE: GSK) today announced the submission of a regulatory
application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for
Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of
shingles (herpes zoster) in adults aged 18 years and older who are at
increased risk. This includes individuals with immunodeficiency or
immunosuppression caused by known disease or therapy. Immunocompromised
individuals are at greater risk of shingles and associated complications than
immunocompetent individuals. i  (#_edn1)

 

Shingrix, a non-live, recombinant sub-unit adjuvanted vaccine given
intramuscularly in two doses, was initially approved in 2018 by the Japanese
MHLW to prevent shingles in adults aged 50 years or older.

 

The MHLW regulatory submission is based on six clinical trials in patients
aged 18 years and older who had undergone recent blood-forming cells (stem
cell) transplantation, kidney transplant, or have blood cancer, solid tumour
or HIV. ii  (#_edn2) (, iii  (#_edn3) , iv  (#_edn4) , v  (#_edn5) , vi 
(#_edn6) , vii  (#_edn7) )

 

In Japan, adults aged 18 years and older who are immunocompromised or have
chronic medical conditions have a higher incidence of shingles, including a
higher risk of developing associated complications such as post-herpetic
neuralgia (PHN), a severe intermittent or continuous long-term nerve pain that
occurs in areas of skin previously affected by shingles. In a retrospective
cohort study using data from Japanese adults aged 18 years and older, the risk
of shingles was higher in women, irrespective of age and increased with
age. viii  (#_edn8)

 

About Shingles

Shingles, also known as herpes zoster, is caused by a reactivation of the
varicella-zoster virus (VZV) - the same virus that causes chickenpox - which
lays dormant in the body after the initial infection. Natural age-related
decline of the immune system can allow VZV to resurface, causing shingles.
People with a suppressed or compromised immune system are also at increased
risk of developing shingles.(i) Globally, over 90% of adults aged 50 years and
older are infected with VZV and are at risk of developing shingles. ix 
(#_edn9) Approximately 600,000 new cases of shingles are reported in Japan
each year. x  (#_edn10)

 

About Shingrix

Shingrix is a non-live, recombinant sub-unit vaccine approved by the Japanese
MHLW on 23 March 2018 to prevent shingles in adults 50 years and older.

 

It combines an antigen, glycoprotein E, and an adjuvant system, AS01B, to
generate a VZV-specific immune response that can help overcome the decline in
VZV immunity as people age. The recombinant shingles vaccine is not indicated
to prevent primary varicella infection (chickenpox).

 

In adults 50 years and older, the vaccine is intended to be administered in
two doses, two to six months apart. However, for adults 18 years and older who
are immunodeficient, immunosuppressed or likely to become immunosuppressed due
to known disease or therapy and who would benefit from a shorter vaccination
schedule, the second dose can be administered one to two months after the
first dose in countries where the indication for this population has been
approved.

 

The European Commission and the United Kingdom approved Shingrix on 25 August
2020 to prevent shingles and PHN in adults aged 18 or older at increased risk
of shingles. On 26 July 2021, the US Food and Drug Administration approved the
vaccine to prevent shingles in adults aged 18 years or older at increased risk
of shingles due to immunodeficiency or immunosuppression caused by known
disease or therapy. The extended indication for preventing shingles and PHN in
adults aged 18 years or older at increased risk of developing shingles has
also recently been approved in Australia.

 

Shingrix is also recommended in the US by the US Centers for Disease Control
and Prevention's Advisory Committee on Immunization Practices as the preferred
vaccine for the prevention of shingles and related complications for
immunocompetent adults aged 50 years and older. xi  (#_edn11)

 

About GSK

GSK is a science-led global healthcare company. For further information,
please visit www.gsk.com/about-us (http://www.gsk.com/about-us) .

 

 

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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 in
the Company's Annual Report on Form 20-F for 2021, GSK's Q1 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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References

 i  (#_ednref1) Mueller, NH et al. Varicella Zoster Virus Infection: Clinical
Features, Molecular Pathogenesis of Disease and Latency. Neurologic Clinics,
2008; 26;675-697.

 ii  (#_ednref2) Bastidas A, et al. JAMA 2019;132:123-133.

 iii  (#_ednref3) Berkowitz EM, et al. J Infect Dis 2015;211:1279-1287.

 iv  (#_ednref4) Vink P, et al. Cancer 2019;125:1301-1312.

 v  (#_ednref5) Dagnew AF, et al. Lancet Infect Dis 2019;19:988-1000.

 vi  (#_ednref6) Vink P, et al. Cancer 2019;125:1301-1312.

 vii  (#_ednref7) Stadtmauer E, et al. Blood. 2014;124(19):2921-2929

 viii  (#_ednref8) Imafuku S et al. Risk of herpes zoster in the Japanese
population with

immunocompromising and chronic disease conditions: Results from a claims
database cohort study, from 2005 to 2014. Journal of Dermatology. 2020. ; 47:
236-244.

 ix  (#_ednref9) Bricout H et al. "Herpes zoster-associated mortality in
Europe: a systematic review." BMC Public Health 15:466 (2015). Available at:
https://doi.org/10.1186/s12889-015-1753-y Last accessed: June 2022.

 x  (#_ednref10) Gnann et al. Clinical practice. Herpes zoster. N Eng J
Med. 2002;347(5):340-6

 xi  (#_ednref11) Dooling KL et al. Recommendations of the Advisory Committee
on Immunization Practices for Use of Herpes Zoster Vaccines. CDC. 2018.
67(3);103-108.

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