FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of September 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
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United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Trixeo approved in EU for asthma
23 September 2026
Trixeo approved
in the EU for the maintenance treatment of
asthma
Trixeo is the first and only triple-combination therapy approved in
the EU for patients 12 years and older, independent of exacerbation
history
AstraZeneca's fixed-dose triple-combination Trixeo Aerosphere
(budesonide/glycopyrronium/formoterol
fumarate dihydrate or BGF (320/28.8/10lg)) has been approved in the
European Union (EU) as a maintenance treatment for asthma in
patients 12 years of age and older who are not adequately
controlled by a combination of a medium dose inhaled corticosteroid
(ICS) and long-acting beta2-agonist (LABA). Trixeo Aerosphere,
marketed as Breztri Aerosphere
in the US, China and Japan, is a
single inhaler that combines the efficacy of ICS/LABA with a
long-acting muscarinic antagonist (LAMA).
The approval by the European Commission (EC) follows the
positive
opinion of the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) and was based on the positive results from
the KALOS and LOGOS Phase III trials. In the trials,
Trixeo demonstrated statistically significant
improvements in lung function compared with combined ICS/LABA
comparators.1 In
the pooled analysis of KALOS and LOGOS, Trixeo demonstrated a
statistically significant reduction
in the annualised rate
of severe asthma exacerbations versus combined
ICS/LABA comparators in a broad population of patients including
those with no asthma exacerbations in the previous
year.1
Alberto Papi, Professor and Chair of Respiratory Medicine at the
University of Ferrara, and Director of the Respiratory Unit,
CardioRespiratory Department, S. Anna University Hospital, Ferrara,
Italy, and primary investigator, said: "Every day, I see patients
whose asthma remains uncontrolled despite maintenance treatment,
leaving them with persistent symptoms like difficulty breathing and
declining lung function and at risk of exacerbations, which can
have serious health consequences. The approval of
Trixeo
in Europe as the first
triple-combination therapy in a single inhaler for patients 12
years of age and older provides an important new treatment option
that has been shown to improve asthma control and reduce future
risk of exacerbations, regardless of exacerbation
history."
Ruud Dobber, Executive Vice President and President,
BioPharmaceuticals Business Unit, AstraZeneca, said: "Today's
approval in asthma builds on Trixeo's established role in improving outcomes in patients
with COPD. This means we can now bring the benefits of a
single-inhaler triple-combination therapy to people aged 12 years
and older in Europe whose asthma remains uncontrolled on dual
inhaled therapy."
In a key secondary endpoint, Trixeo demonstrated a rapid onset of action with a
significant improvement from baseline in lung function within five
minutes after the first dose.1 Trixeo
is a maintenance therapy and is not
used to relieve sudden breathing problems and will not replace a
rescue inhaler. Results from KALOS and LOGOS
were published in The
Lancet Respiratory Medicine in February
2026.1
There were no new safety or
tolerability signals identified for Trixeo in the trials.1
In Europe, there are nearly 43 million people living with asthma,
and every year, about four million more people are newly
diagnosed.2
When uncontrolled on dual therapies,
patients can often struggle with symptoms such as wheezing,
breathlessness, coughing, exacerbations and even
death.3-5
Trixeo/Breztri, is also
approved in the US and Japan for treatment of asthma and is currently
under review in China, as well as other countries.
Trixeo/Breztri
is also approved for the treatment of
COPD in adults in 90 countries worldwide including the US, EU,
China and Japan.
Notes
Asthma
Asthma is a prevalent, chronic respiratory disease affecting as
many as 363 million people worldwide, including nearly 43 million
people in Europe.2,6
Around half of patients continue to be
uncontrolled on dual therapies, leading to inflammation and muscle
tightening in the airway (bronchoconstriction) that cause wheezing,
breathlessness, chest tightness, coughing, exacerbations and even
death.3-5
Many patients remain uncontrolled
despite the availability of standard of care medicines and continue
to experience significant limitations on lung function and reduced
quality of life.4,5
KALOS and LOGOS Phase III trials
KALOS and LOGOS were replicate confirmatory, randomised,
double-blind, double-dummy, parallel group, multi-centre,
24-to-52-week variable length Phase III trials to assess the
efficacy and safety of Breztri/Trixeo Aerosphere compared
with two fixed-dose, dual-combination therapies of budesonide, an
ICS, and formoterol fumarate, a LABA: Symbicort pressurised
metered-dose inhaler (pMDI) and PT009 (in an Aerosphere
formulation).1,7,8
KALOS and LOGOS included
approximately 4,300 randomised patients.7,8
In the data package submitted to the EMA, in the individual trials,
the primary lung function endpoint was change from baseline in
morning pre-dose trough FEV1 over
24 weeks, and the key secondary endpoint was change from baseline
in FEV1 AUC0-3
over 24 weeks, versus dual therapy
(the ICS/LABA treatment groups combined).1
The pooled primary endpoint using data
from both KALOS and LOGOS trials, and prioritised in the testing
procedure, was the rate of severe asthma exacerbations versus dual
therapy (ICS/LABA) treatment groups combined.1
The primary and secondary endpoints
and treatment comparisons in the KALOS and LOGOS trials differed
according to regulatory submission approaches.1
Breztri/Trixeo Aerosphere
Budesonide/glycopyrronium/formoterol fumarate or
budesonide/glycopyrrolate/formoterol fumarate, is approved under
the brand name Breztri
Aerosphere in Japan, China
and the US, and Trixeo
Aerosphere (budesonide/glycopyrronium/formoterol
fumarate dihydrate) in the EU, as a single-inhaler, fixed-dose
triple-combination of formoterol fumarate, a LABA, glycopyrronium
bromide, a LAMA, with budesonide, an ICS, and delivered via
the Aerosphere pMDI.
Breztri/Trixeo is approved in
the US, Europe and Japan to treat asthma in patients 12 years of
age and older. Regulatory filings for Breztri/Trixeo
in asthma are currently under review
in all other major regions.
Breztri /Trixeo is also
approved for the treatment of COPD in more than 90 countries
worldwide including the US, EU, China, and Japan, and was
prescribed to more than 6.8 million patients globally in
2025.9
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of AstraZeneca
BioPharmaceuticals, is a key disease area and growth driver to the
Company.
AstraZeneca is an established leader in respiratory care with a
50-year heritage and a growing portfolio of medicines in
immune-mediated diseases. The Company is committed to addressing
the vast unmet needs of these chronic, often debilitating, diseases
with a pipeline and portfolio of inhaled medicines, biologics and
new modalities aimed at previously unreachable biologic targets.
Our ambition is to deliver life-changing medicines that help
eliminate COPD as a leading cause of death, eliminate asthma
attacks and achieve clinical remission in immune-mediated
diseases.
AstraZeneca
AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Disease, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca's innovative
medicines are sold in more than 125 countries and used by millions
of patients worldwide. Please visit astrazeneca.com
and follow the Company on Social
Media @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Papi A, Wise R, Jackson D et
al. Budesonide-glycopyrronium-formoterol
fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin
multicentre, double-blind, double-dummy, parallel-group,
randomised, phase 3 trials. The Lancet Respiratory
Medicine.
2026;14:350-362.
2. International Respiratory
Coalition. Asthma. [Online]. Available at: https://international-respiratory-coalition.org/diseases/asthma/.
[Last accessed: September 2026].
3. Fernandes AG, et al. Risk factors
for death in patients with severe asthma. J Bras
Pneumol.
2014;40(4):364-372.
4. Davis J, et al. Burden of asthma
among patients adherent to ICS/LABA: A real-world study.
J
Asthma. 2019
Mar;56(3):332-340.
5. Buhl R, et al. One-year follow up
of asthmatic patients newly initiated on treatment with medium- or
high-dose inhaled corticosteroid-long-acting b2-agonist in UK
primary care settings. Respir Med. 2020 Feb;162:105859.
6. World Health Organization. Asthma.
[Online]. Available at: https://www.who.int/news-room/fact-sheets/detail/asthma.
[Last accessed: September
2026].
7. Clinicaltrials.gov. Study to Assess
PT010 in Adult and Adolescent Participants with Inadequately
Controlled Asthma (KALOS) [Online]. Available
at: https://clinicaltrials.gov/study/NCT04609878?limit=25&term=KALOS&rank=1.
[Last accessed: September 2026].
8. Clinicaltrials.gov. Study to Assess
PT010 in Adult and Adolescent Participants with Inadequately
Controlled Asthma (LOGOS) [Online]. Available
at: https://clinicaltrials.gov/study/NCT04609904?limit=25&term=LOGOS&rank=4.
[Last accessed: September 2026].
9.
AstraZeneca. Data On File. REF-325003.
Matthew Bowden
Company Secretary
AstraZeneca PLC
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 authorized.
Date: 23 September 2026
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By: /s/
Matthew Bowden
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Name:
Matthew Bowden
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Title:
Company Secretary
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