UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR
15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the
month of August 2025
Commission
File Number 001-15170
GSK plc
(Translation
of registrant's name into English)
79 New Oxford Street, London, WC1A 1DG
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form
20-F . . . .X. . . . Form 40-F . . . . . . . .
Issued:
11 August 2025, London UK
Gepotidacin accepted for priority review by the US FDA for the oral
treatment of uncomplicated urogenital gonorrhoea
● Submission supported by positive phase III data
in patients with uncomplicated urogenital gonorrhoea in EAGLE 1
trial[1]
● Significant need for new antibiotics for
gonorrhoea, a priority pathogen for the World
Health Organization[2]
● If approved, gepotidacin would offer a new oral
option to US patients currently relying on injectable
treatments
● US decision expected in December
2025
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted for priority review a
supplemental New Drug Application for gepotidacin as an oral option
for the treatment of uncomplicated urogenital gonorrhoea in
patients 12 years of age and older (weighing ≥45 kg). The US FDA has assigned a
Prescription Drug User Fee Act action date in December 2025. In
March 2025, gepotidacin was approved by the US FDA under the
licensing name Blujepa as oral treatment for female adult and
paediatric patients 12 years of age and older
(weighing ≥40 kg) with uncomplicated urinary tract infection
(uUTI).[3]
Gonorrhoea is a common, sexually transmitted infection caused
by Neisseria
gonorrhoeae, which has been
recognised by the World Health Organization as a priority
pathogen2 and an urgent public health threat by the US
Centers for Disease Control and Prevention
(CDC).[4] It
affects both men and women and if left untreated or inadequately
treated, it can lead to infertility and other sexual and
reproductive health complications. There were more than 600,000
cases of gonorrhoea reported in the United States in 2023 according
to the CDC, making it the second most commonly reported sexually
transmitted infection in the country.[5] There
is currently no vaccine licensed in the US for the prevention of
gonorrhoea infection and the standard of care is injectable
treatment which may not be suitable or available for all
patients.[6]
The US application is based on results from the EAGLE-1 phase III
trial recently published in The Lancet, showing that gepotidacin (oral, two doses of
3,000mg) was non-inferior, with 92.6% (187/202, [95% CI 88·0 to 95·8]) success rates at
urogenital site when compared to 91.2% (186/204, [95% CI
86.4-94.7]) success rates for intramuscular ceftriaxone
(500mg) plus oral azithromycin (1,000mg) combined therapy, a
leading combination treatment regimen for gonorrhoea. Additionally,
there were no failures at the urogenital site due to bacterial
persistence of N.
gonorrhoeae in either
treatment arm. The safety and tolerability profile of gepotidacin
in the EAGLE-1 trial was consistent with results seen in previous
clinical trials, with no serious drug related adverse events
observed in either the gepotidacin or the comparator arm. The most
common reported adverse reactions were mild to moderate
gastrointestinal events.1
This is
the second major indication filed in the US for gepotidacin, and
review of regulatory submissions for the uUTI indication is also
ongoing in the UK and Australia.
The
development of gepotidacin has been funded in part with
federal funds from the US Department of Health and Human Services,
Administration for Strategic Preparedness and Response, Biomedical
Advanced Research and Development Authority (BARDA), under Other
Transaction Agreement number HHSO100201300011C and with federal
funds awarded by the US Department of Defense's Threat Reduction
Agency under agreement number HDTRA1-07-9-0002.
About gepotidacin
Gepotidacin, discovered by GSK scientists, is a bactericidal,
first-in-class triazaacenaphthylene antibiotic that inhibits
bacterial DNA replication by a distinct binding site, a novel
mechanism of action, and for most pathogens, provides well-balanced
inhibition of two different Type II topoisomerase enzymes. This
provides activity against Neisseria
gonorrhoeae and most
target uropathogens (such as Escherichia
coli and Staphylococcus
saprophyticus), including
isolates resistant to current antibiotics. Due to this
well-balanced inhibition for most pathogens, a single
target-specific mutation may not significantly impact gepotidacin
activity.
The US
Prescribing Information is available here.
About the EAGLE clinical programme
The
EAGLE-1 trial (NCT04010539) is part of a comprehensive global phase
III clinical programme for gepotidacin in adults and adolescents
including:
EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the
efficacy and safety of gepotidacin (oral, two doses of
3,000mg) to intramuscular ceftriaxone (500mg) plus oral azithromycin
(1,000mg) in approximately 600 patients with uncomplicated
urogenital gonorrhoea. The data were presented at ESCMID in April
2024[7] and
published in The Lancet in April 2025.1
EAGLE-2
and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and
safety of gepotidacin (1,500mg administered orally twice daily for
five days) to nitrofurantoin (100mg administered orally twice daily
for five days). The data were first presented at European Congress
of Clinical Microbiology and Infectious Diseases (ECCMID) in
2023.[8]
GSK in infectious diseases
GSK has
pioneered innovation in infectious diseases for over 70 years, and
the Company's pipeline of medicines and vaccines is one of the
largest and most diverse in the industry, with a goal of developing
preventive and therapeutic treatments for multiple disease areas or
diseases with high unmet needs globally. Our expertise and
capabilities in infectious disease strongly position us to help
prevent disease and mitigate the challenge of antimicrobial
resistance (AMR).
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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Alison
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Investor
Relations:
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Constantin
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+44 (0)
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James
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+44 (0)
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(London)
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Jeff
McLaughlin
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+1 215
751 7002
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(Philadelphia)
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Frannie
DeFranco
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+1 215
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(Philadelphia)
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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 "Risk
Factors" section in GSK's Annual Report on Form 20-F for 2024, and
GSK's Q2 Results for 2025.
Registered
in England & Wales:
No.
3888792
Registered
Office:
79 New
Oxford Street
London
WC1A
1DG
References
[1] Ross J et al, "Oral gepotidacin for the treatment
of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3
randomised, open-label, non-inferiority, multicentre study"
in The Lancet, 2025; 405: 1608-20; https://doi.org/10.1016/S0140-6736(25)00628-2
[2] WHO. bacterial priority pathogens list, 2024:
Bacterial pathogens of public health importance to guide research,
development and strategies to prevent and control antimicrobial
resistance. Available at: https://www.who.int/publications/i/item/9789240093461 Last
accessed: August 2025
[3] GSK. Blujepa approved by US FDA for treatment of
uncomplicated urinary tract infections. Available
at: https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/ Last
accessed: August 2025
[4] CDC. Antibiotic Resistance Threats Report.
Available at: https://www.cdc.gov/antimicrobial-resistance/media/pdfs/covid19-impact-report-508.pdf Last
accessed: August 2025
[5] CDC. National Overview of STIs in 2023. Available
at: https://www.cdc.gov/sti-statistics/annual/summary.html.
Last accessed: August 2025
[6] CDC. STI treatment guideline.
Available: https://www.cdc.gov/std/treatment-guidelines/default.htm Last
accessed: August 2025
[7] GSK. EAGLE 1 phase III data show potential for
gepotidacin as a new oral treatment option for uncomplicated
urogenital gonorrhoea (GC) amid growing resistance to existing
treatments. Available at:https://www.gsk.com/en-gb/media/press-releases/eagle-1-phase-iii-data-show-potential-for-gepotidacin-as-a-new-oral-treatment-option-for-uncomplicated-gc/ Last
accessed: August 2025.
[8] GSK. Gepotidacin's positive phase III data shows
potential to be the first in a new class of oral antibiotics for
uncomplicated urinary tract infections in over 20 years. Available
at: https://www.gsk.com/en-gb/media/press-releases/gepotidacin-s-positive-phase-iii-data-shows-potential-to-be-the-first-in-a-new-class-of-oral-antibiotics-for-uncomplicated-urinary-tract-infections/ Last
accessed: August 2025.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorised.
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GSK plc
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(Registrant)
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Date: August
11, 2025
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By:/s/ VICTORIA
WHYTE
--------------------------
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Victoria Whyte
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Authorised
Signatory for and on
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behalf
of GSK plc
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