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 March 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:
25 March 2025, London UK
Blujepa (gepotidacin) approved by US
FDA for treatment of uncomplicated urinary tract infections (uUTIs)
in female adults and paediatric patients 12 years of age and
older
●
Blujepa is
the first in a new class of oral antibiotics for uUTIs in nearly 30
years
●
Over
half of all women experience a uUTI in their lifetime, with
approximately 30% suffering from a recurrent
episode
●
Approval
based on data from the pivotal phase III EAGLE-2 and EAGLE-3
trials
GSK plc
(LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved Blujepa (gepotidacin) for the
treatment of female adults (≥40 kg) and paediatric patients
(≥12 years, ≥40 kg) with uncomplicated urinary tract
infections (uUTIs) caused by the following susceptible
microorganisms: Escherichia
coli, Klebsiella
pneumoniae, Citrobacter
freundii complex, Staphylococcus
saprophyticus and Enterococcus faecalis.
Discovered
by GSK scientists, Blujepa is a first-in-class oral
antibiotic with a novel mechanism of action that is part of GSK's
infectious diseases portfolio.
Tony Wood, Chief Scientific Officer, GSK, said: "The approval of Blujepa is a crucial milestone with uUTIs among the most
common infections in women. We are proud to have
developed Blujepa, the first in a new class of oral antibiotics
for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising
rates of resistance to existing treatments."[1][2][3][4]
uUTIs
are the most common infection in women, impacting up to 16 million
women in the US annually.1-4 Over half of
all women are affected by uUTI in their lifetime,[5] with
approximately 30% suffering from at least one recurrent episode
which can cause significant patient burden, including discomfort
and restriction of daily activities.[6] New
treatments are needed as the number of uUTIs caused by
drug-resistant bacteria is increasing which can result in higher
treatment failure rates.[7]
Thomas Hooton, MD, Professor of Clinical Medicine, University of
Miami School of Medicine said: "For many, uUTIs can be a burden that severely
impacts daily life. With an increasing number of patients
experiencing recurrent infections, there remains a clear need for
continued research of antimicrobials to help address ongoing
patient challenges and the strain on healthcare
systems."
The approval is based on positive results from the pivotal phase
III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority
to nitrofurantoin, one of the leading current standard of care
options for uUTI, in female adults (≥40 kg) and paediatric
patients (≥12 years, ≥40 kg) with a confirmed
uUTI. In EAGLE-2, Blujepa demonstrated non-inferiority in therapeutic
success which occurred in 50.6% (162/320) of participants compared
to 47.0% (135/287) for nitrofurantoin (covariate-adjusted treatment
difference 4.3%, 95% CI (-3.6, 12.1)). In EAGLE-3, Blujepa demonstrated statistically significant superiority versus
nitrofurantoin (one-sided p-value 0.0003). Therapeutic success occurred in 58.5% (162/277)
of participants compared to 43.6% (115/264) for nitrofurantoin
(covariate-adjusted treatment difference 14.6%, 95% CI (6.4,
22.8)).
The safety and tolerability profile of Blujepa in the EAGLE-2 and EAGLE-3 phase III trials
was consistent with previous trials. The most commonly reported
adverse events (AEs) in Blujepa participants were gastrointestinal (GI).
Diarrhoea was the most common (16% of participants), followed by
nausea (9%). Of the participants who reported GI AEs in
the Blujepa group, the most common maximum severity was
mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for
3% of all patients with GI events and occurred in <1% of all
participants. There was one drug-related serious adverse event in
each treatment arm (Blujepa and nitrofurantoin) across the two
trials.
US
commercial launch is planned in 2H 2025.
The
development of Blujepa (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 Defense Threat Reduction
Agency under agreement number HDTRA1-07-9-0002.
About Blujepa (gepotidacin)
Blujepa, 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 most target
uropathogens (such as Escherichia
coli and Staphylococcus
saprophyticus),
and Neisseria
gonorrhoeae, including
isolates resistant to current antibiotics. Due to the well-balanced
inhibition for most pathogens, Blujepa target-specific mutations in both enzymes
are needed to significantly affect susceptibility
to Blujepa. Therefore, a lower potential for resistance
development is expected. Efficacy and safety in patients have been
demonstrated in uUTI and gonorrhoea phase III clinical trials,
including in patients with drug-resistant pathogens. The US
Prescribing Information is available here.
About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated)
phase III programme
The
global phase III clinical programme for Blujepa (gepotidacin) in adults
and paediatric patients consists of three trials:
EAGLE-2
and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and
safety of Blujepa (1,500mg administered
orally twice daily for five days) to nitrofurantoin (100mg
administered orally twice daily for five days) with 1531 and 1605
female adults and paediatric patients with uUTIs, respectively.
Across both trials, the planned duration of follow-up for
participants was approximately 28 days, and the primary endpoint, a
stringent composite measure of efficacy, was the combined clinical
and microbiological response at the Test-of-Cure (ToC) visit (days
10-13) in patients with qualifying uropathogens susceptible to
nitrofurantoin.
EAGLE-1
(non-inferiority uncomplicated urogenital gonorrhoea trial)
compared the efficacy and safety of Blujepa to ceftriaxone plus
azithromycin in 628 patients with uncomplicated urogenital
gonorrhoea caused by N.
gonorrhoeae.
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).
In
antimicrobials, in addition to gepotidacin, GSK entered into an
exclusive licence agreement with Spero Therapeutics, Inc. in
September 2022 to add tebipenem HBr, a late-stage antibiotic and
potential treatment for complicated urinary tract infections
(cUTIs), to the pipeline and are currently enrolling for PIVOT-PO,
a phase III trial. In March 2023, GSK announced an exclusive
licence agreement with Scynexis for Brexafemme (ibrexafungerp
tablets), a first-in-class antifungal for the treatment of
vulvovaginal candidiasis (VVC) and reduction in the incidence of
recurrent VVC.
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
|
|
|
|
|
Media:
|
Tim
Foley
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Sarah
Clements
|
+44 (0)
20 8047 5502
|
(London)
|
|
|
Kathleen
Quinn
|
+1 202
603 5003
|
(Washington
DC)
|
|
|
Lyndsay
Meyer
|
+1 202
302 4595
|
(Washington
DC)
|
|
|
|
|
|
|
Investor
Relations:
|
Constantin
Fest
|
+44 (0)
7831 826525
|
(London)
|
|
|
Annabel
Brownrigg-Gleeson
|
+44 (0)
7901 101944
|
(London)
|
|
|
James
Dodwell
|
+44 (0)
20 8047 2406
|
(London)
|
|
|
Mick
Readey
|
+44 (0)
7990 339653
|
(London)
|
|
|
Steph
Mountifield
|
+44 (0)
7796 707505
|
(London)
|
|
|
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 in the "Risk
Factors" section in GSK's Annual Report on Form 20-F for
2024.
Registered
in England & Wales:
No.
3888792
Registered
Office:
79 New
Oxford Street
London
WC1A
1DG
References
[1] Advani SD, et al. Poster presented at:
ISPOR 2024; May 5-8, 2024. Presentation EPH17.
[2] Foxman B, et al. Urinary tract infection:
self-reported incidence and associated
costs. Ann
Epidemiol.
2000;10(8):509-15.
[3] Foxman B. Urinary Tract Infection Syndromes:
Occurrence, Recurrence, Bacteriology, Risk Factors, and Disease
Burden. Infect Dis Clin North
Am. 2014
28(1):1-13.
[4] United States Census Bureau. Age and Sex
Composition: 2020. [Available from: https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-06.pdf Last
accessed March 2025].
[5] Czajkowski, K, et al. Urinary tract infection in
women. Prz
Menopauzalny.
2021;20(1):40-7.
[6] Little P, et al. Presentation, pattern, and
natural course of severe symptoms, and role of antibiotics and
antibiotic resistance among patients presenting with suspected
uncomplicated urinary tract infection in primary care:
observational study. BMJ. 2010;340:b5633.
[7] Kaye KS, et al. Antimicrobial resistance trends
in urine Escherichia coli isolates from adult and adolescent
females in the United States from 2011 to 2019: rising ESBL strains
and impact on patient management. Clin Infect
Dis 2021;73:1992-1999.
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.
|
|
GSK plc
|
|
|
(Registrant)
|
|
|
|
|
Date: March
25, 2025
|
|
|
|
|
|
|
By:/s/ VICTORIA
WHYTE
--------------------------
|
|
|
|
|
|
Victoria Whyte
|
|
|
Authorised
Signatory for and on
|
|
|
behalf
of GSK plc
|