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 CRM197 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),
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.[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.[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.
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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 "Risk factors" in the
company's Annual Report on Form 20-F for 2023.
Registered in England & Wales:
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TW8 9GS
[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.
[7]. Thompson
MJ et al. Clinical recognition of
meningococcal disease in children and adolescents. Lancet.
2006. 367, 397-403.
[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.
[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.
Accessed April 2024.