REG - GSK PLC - GSK uUTI treatment approved by US FDA

GSKAnnouncement

25/03/2025 16:45

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RNS Number : 1202C  GSK PLC  25 March 2025

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  (#_edn1)  2  (#_edn2)  3  (#_edn3)  4  (#_edn4)

 

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  (#_edn5) with approximately 30% suffering from at least one
recurrent episode which can cause significant patient burden, including
discomfort and restriction of daily activities. 6  (#_edn6) 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  (#_edn7)

 

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
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Blujepa/pdf/BLUJEPA-MG.PDF)
.

 

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.

 

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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.

 

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References

 1  (#_ednref1)  Advani SD, et al. Poster presented at: ISPOR 2024; May 5-8,
2024. Presentation EPH17.

 2  (#_ednref2)  Foxman B, et al. Urinary tract infection: self-reported
incidence and associated costs. Ann Epidemiol. 2000;10(8):509-15.

 3  (#_ednref3) 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  (#_ednref4)  United States Census Bureau. Age and Sex Composition: 2020.
[Available from:
https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-06.pdf
(https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-06.pdf)
Last accessed March 2025].

 5  (#_ednref5) Czajkowski, K, et al. Urinary tract infection in women. Prz
Menopauzalny. 2021;20(1):40-7.

 6  (#_ednref6) 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  (#_ednref7) 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.

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