REG - GSK PLC - FDA accepts GSK meningitis vaccine candidate file

GSKAnnouncement

16/04/2024 07:00

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RNS Number : 7012K  GSK PLC  16 April 2024

Issued: 16 April 2024, London UK

 

GSK's 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory
review by US FDA

 

·      Vaccine candidate provides broad coverage against the five most
common groups of bacteria causing invasive meningococcal disease and could
reduce number of injections to simplify immunisation, if approved

·      Prescription Drug User Fee Act action date set by FDA for 14
February 2025

·      Submission based on results from pivotal phase III trial showing
all primary endpoints met

 

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted for review a Biologics License Application
(BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate. The
Prescription Drug User Fee Act (PDUFA) action date for a regulatory decision
by the US FDA on this application is 14 February 2025.

 

GSK's 5-in-1 MenABCWY vaccine candidate combines the antigenic components of
its two well-established meningococcal vaccines with demonstrated efficacy and
safety profiles, Bexsero (Meningococcal Group B Vaccine) and Menveo
(Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM(197)
Conjugate Vaccine).  The MenABCWY combination will target the five groups of
the bacteria Neisseria meningitidis (Men A, B, C, W and Y) that cause most
invasive meningococcal disease (IMD) cases globally. 1 

 

Combining the protection offered by these vaccines into fewer shots aims to
reduce the number of injections, simplifying immunisation. This can help
increase series completion and vaccination coverage and help reduce the
overall burden of IMD, with unvaccinated adolescents being at particular risk
of infection and potential outbreaks. 2 (, 3 , 4 )

 

IMD is an unpredictable but serious illness that can cause life-threatening
complications. 5  Despite treatment, among those who contract IMD one in six
will die, sometimes in as little as 24 hours. 6 (, 7 ) One in five survivors
may suffer long-term consequences such as brain damage, amputations, hearing
loss and nervous system problems. 8   Although anyone can get IMD, those who
are in their late teens and early adulthood are amongst the groups at higher
risk of contracting it. 9 (, 10 )

 

In the US, while meningococcal vaccine recommendations for all five serogroups
have been in place since 2015, annual immunisation rates for IMD have remained
low overall, due in part to a complex schedule. 11  MenB is the most common
group of IMD-causing bacteria in US adolescents and young adults, accounting
for more than half of the IMD cases among this age group in the US from
2017-2021. 12  For protection against MenB, which is subject to the shared
clinical decision-making recommendation of the CDC, just under 12% of US
adolescents have had the two required doses.10

 

In the phase III trial (NCT04502693
(https://clinicaltrials.gov/study/NCT04502693) ), all primary endpoints were
achieved for the MenABCWY vaccine candidate, including immunological
non-inferiority to one dose of GSK's Meningococcal Groups A,C,Y and W Vaccine,
and non-inferior immune responses against 110 diverse MenB invasive strains
(representing 95% of MenB strains circulating in the US) as compared to two
doses of GSK's Meningococcal Group B Vaccine. The vaccine was well tolerated
with a safety profile consistent with both vaccines. 13 

 

 

 

About the MenABCWY phase III trial

The trial conducted by GSK was a phase III randomised, controlled,
observer-blind, multi-country trial to evaluate the safety, tolerability and
immunogenicity of GSK's MenABCWY vaccine candidate. The trial started in
August 2020, and approximately 3,650 participants aged 10-25 were enrolled in
the US, Canada, Czech Republic, Estonia, Finland, Turkey and Australia.

 

The objective of the trial was to assess the safety profile of the MenABCWY
vaccine candidate, to assess the

immunological vaccine effectiveness against a panel of 110 MenB strains and to
demonstrate non-inferiority of the immune responses of the trial's
participants who received two doses of the MenABCWY vaccine candidate six
months apart to the responses of those in the control groups who received
GSK's licensed vaccines: two doses of   Meningococcal Group B Vaccine and
one dose of Meningococcal Groups A,C,Y and W Vaccine.

 

About Bexsero

Bexsero is currently licensed or has received regulatory approval in 55
countries, including the US and EU, and is used in 16 national immunisation
programmes worldwide for the prevention of IMD caused by Neisseria
meningitidis serogroup B. In the US, it is licensed under the Accelerated
Approval pathway for active immunisation to prevent IMD caused by Neisseria
meningitidis serogroup B in individuals from 10 through 25 years. As required
under the FDA's Accelerated Approval regulations, GSK has completed a
confirmatory trial of this vaccine and submitted a supplemental Biologics
License Application (sBLA) to convert the accelerated approval to full
approval. The US Prescribing Information is available here
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF)
. 14 

 

About Menveo

Menveo has received regulatory approval in over 60 countries, including the
US, with more than 72 million doses distributed worldwide since 2010. It
offers extensive evidence of immunogenicity with a well-characterised safety
profile. In the US, this vaccine has received regulatory approval for active
immunisation to prevent IMD caused by Neisseria meningitidis serogroups A, C,
Y, and W in individuals from 2 months through 55 years of age.  The US
Prescribing Information is available here
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF)
. 15 

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com.

 

 GSK enquiries
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                      Jeff McLaughlin    +1 215 751 7002       (Philadelphia)
                      Frannie DeFranco   +1 215 751 4855       (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 "Risk factors" in the company's Annual Report on Form 20-F for 2023.

 

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Registered Office:

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 1 . CDC. Meningococcal Disease Causes and How It Spreads. Available at:
https://www.cdc.gov/meningococcal/about/causes-transmission.html
(https://www.cdc.gov/meningococcal/about/causes-transmission.html) . Accessed
April 2024.

 2 . Bekkat-Berkani R, Fragapane E, Preiss S, Rappuoli R et al. Public health
perspective of a pentavalent meningococcal vaccine combining antigens of
MenACWY-CRM and 4CMenB, Journal of Infection Vol 85, Issue 5, p481-491,
published November 2022.

 3 . Huang L, Snedecor S et al. Potential public health impact of a Neisseria
meningitidis A, B, C, W, and Y pentavalent vaccine in the United States,
Postgraduate Medicine, 134(4):341-348 published May 2022.

 4 . CDC. University-Based Outbreaks of Meningococcal Disease Caused by
Serogroup B, United States, 2013-2018 - Volume 25, Number 3-March 2019 -
Emerging Infectious Diseases journal - CDC. Available at:
https://wwwnc.cdc.gov/eid/article/25/3/18-1574_article. Accessed April 2024.

 5 . CDC. Bacterial Meningitis, Available at:
www.cdc.gov/meningitis/bacterial.html
(http://www.cdc.gov/meningitis/bacterial.html) . Accessed April 2024.

 6 . World Health Organisation. Meningitis fact sheet. Available at:
https://www.who.int/news-room/fact-sheets/detail/meningitis
(https://www.who.int/news-room/fact-sheets/detail/meningitis) . Accessed April
2024.

 7 . Thompson MJ et al. Clinical recognition of meningococcal disease in
children and adolescents. Lancet. 2006. 367, 397-403.

 8 . CDC. Meningococcal disease: clinical information. Available at:
https://www.cdc.gov/meningococcal/clinical-info.html
(https://www.cdc.gov/meningococcal/clinical-info.html) . Accessed April 2024.

 9 . McNamara LA, Blain A. Meningococcal Disease  Roush SW, Baldy LM, Hall
MAK, eds. Manual for the Surveillance of Vaccine-Preventable Diseases. Centers
for Disease Control and Prevention. Reviewed January 5, 2022. Accessed April
2024.

 10 . Pingali C, Yankey D, Elam-Evans LD, et al. Vaccination coverage among
adolescents aged 13-17 years - National Immunization Survey-Teen, United
States, 2022. MMWR 2023; 72(34): 912-919.

 11 . Schillie S. Revising the Adolescent Meningococcal Vaccine Schedule: Term
of Reference and Considerations. Available at:
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-02-28-29/02-Meningitis-Schillie-508.pdf
(https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2024-02-28-29/02-Meningitis-Schillie-508.pdf)
. Accessed April 2024.

 12 . CDC. Enhanced Meningococcal Disease Surveillance Reports, 2017-2021.
Available at:
www.cdc.gov/meningococcal/surveillance/index.html#enhanced-reports
(http://www.cdc.gov/meningococcal/surveillance/index.html#enhanced-reports) .
Accessed April 2024.

 13 . NIH. Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal
Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults,
ClinicalTrials.gov. Available at: https://clinicaltrials.gov/study/NCT04502693
(https://clinicaltrials.gov/study/NCT04502693) . Accessed April 2024.

 14 . GSK. Highlights Of Prescribing Information Bexsero. Available at:
gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF)
. Accessed April 2024.

 15 . GSK. Highlights Of Prescribing Information Menveo. Available at:
gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF)
. Accessed April 2024.

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