REG - AstraZeneca PLC - Breztri approved in the US for asthma

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RNS Number : 1860C  AstraZeneca PLC  28 April 2026

28 April 2026

 

Breztri approved in the US for asthma as first and only triple therapy for
patients 12 years of age and older

 

Approval based on KALOS and LOGOS Phase III trials demonstrating statistically
significant and clinically meaningful benefits of AstraZeneca's single-inhaler
fixed-dose triple therapy compared with inhaled dual therapy

 

Approval is second indication for Breztri beyond COPD

 

AstraZeneca's fixed-dose triple-combination therapy Breztri Aerosphere
(budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been
approved in the US for the maintenance treatment of asthma in adult and
paediatric patients 12 years of age and older. Breztri is a single-inhaler
that combines the efficacy of corticosteroid/long-acting beta2-agonist
(ICS/LABA) medicines with a long-acting muscarinic antagonist (LAMA). Breztri
(320/18/9.6μg) was approved in the US in 2020 to treat adults with chronic
obstructive pulmonary disease (COPD) and was prescribed to more than 6.8
million patients globally in 2025.(1,2)

 

The approval by the US Food and Drug Administration (FDA) was based on
efficacy and safety data from the Phase III KALOS and LOGOS trials
investigating Breztri in a broad population consisting of patients with
asthma, with or without a recent asthma exacerbation.(3) In these trials,
Breztri demonstrated a statistically significant and clinically meaningful
improvement in lung function compared with dual-combination inhaled
ICS/LABA.(3) In a key secondary endpoint, Breztri also demonstrated a rapid
onset of action with a significant improvement from baseline in lung function
within five minutes after the first dose.(3) Breztri is a maintenance therapy
and is not used to relieve sudden breathing problems and will not replace a
rescue inhaler.

 

Njira Lugogo, MD, Clinical Professor, Division of Pulmonary and Critical Care
Medicine, Department of Internal Medicine, University of Michigan,
said: "Despite the availability of dual maintenance therapy, many patients
are still at risk for exacerbations and experience daily breathing
difficulties, reduced lung function and the ongoing fear of worsening
symptoms. The FDA approval of Breztri as the only maintenance triple therapy
for people with asthma 12 years of age and older marks a pivotal moment in
helping those living with this debilitating disease breathe better, sooner."

 

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit,
AstraZeneca, said: "As the fastest growing fixed-dose triple-combination
therapy in COPD, Breztri is already improving outcomes for people suffering
with COPD, and we are proud to extend its benefits to asthma patients. The
FDA's approval of Breztri in asthma demonstrates how our innovative science
continues to bring new solutions for patients with respiratory diseases."

 

There are 27 million people living with asthma in the US,(4) around half of
whom 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.(5-7)
Nearly 10 million asthma attacks still occur each year in the US.(4)

 

Results from KALOS and LOGOS
(https://www.astrazeneca.com/media-centre/press-releases/2026/positive-and-clinically-meaningful-results-from-the-phase-iii-kalos-and-logos-trials-for-breztri.html)
were published in The Lancet Respiratory Medicine
(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(25)00457-6/abstract)
in February 2026.(3) There were no new safety or tolerability signals
identified for Breztri in the trials.(3)

 

Breztri is a single-inhaler fixed-dose triple-combination therapy approved for
the treatment of COPD in adults in 90 countries worldwide including the US,
EU, China and Japan. Regulatory filings for Breztri in asthma are currently
under review in other major regions including the EU, Japan and China.

Notes

 

Asthma

Asthma is a prevalent, chronic respiratory disease affecting as many as 262
million people worldwide,(8) including 27 million in the US.(4) When
uncontrolled, inflammation and muscle tightening in the airway
(bronchoconstriction) may cause wheezing, breathlessness, chest tightness,
coughing, and even death.(5-7) 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.(6,7)

 

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 Aerosphere
compared with Symbicort (budesonide/formoterol fumarate, a marketed
therapeutic option), PT009 (budesonide/formoterol fumarate in an Aerosphere
formulation) and the Symbicort and PT009 treatment groups combined.(3,9,10)
KALOS and LOGOS included approximately 4,300 randomised patients.

 

The primary endpoints for the two individual trials were a change from
baseline in forced expiratory volume in 1 second (FEV(1)) area under the curve
0 to 3 hours (AUC(0-3)) at Week 24 and trough FEV(1) over 12-24 weeks and over
24 weeks.(3,9)(,10) The primary endpoints and treatment comparisons in the
KALOS and LOGOS trials differed according to regulatory submission approaches.
In the data package submitted to the US FDA, the primary lung
function endpoint was change from baseline in FEV(1) AUC(0-3) at week 24, and
the key secondary endpoint was change from baseline in morning pre-dose trough
FEV(1) at week 24, compared to PT009.(3)

 

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 in
the EU, is a single-inhaler, fixed-dose triple-combination of formoterol
fumarate, a LABA, glycopyrronium bromide, a long-acting muscarinic antagonist
(LAMA), with budesonide, an ICS, and delivered via
the Aerosphere pMDI. Breztri/Trixeo Aerosphere is approved to treat adults
with COPD in 90 countries worldwide including the US, EU, China, Japan, and
was prescribed to more than 6.8 million patients globally in 2025.(2)

 

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 (https://www.astrazeneca.com/)

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 Diseases, 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 (http://www.astrazeneca.com/) and follow the
Company on Social Media @AstraZeneca
(https://www.linkedin.com/company/astrazeneca) .

Contacts

For details on how to contact the Investor Relations Team, please click here
(https://www.astrazeneca.com/investor-relations.html#Contacts) . For Media
contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html)
.

 

References

1.   AstraZeneca. Breztri Aerosphere approved in the US for the maintenance
treatment of COPD. Press Release. 24 July 2020. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2020/breztri-aerosphere-approved-in-the-us-for-copd.html
(https://www.astrazeneca.com/media-centre/press-releases/2020/breztri-aerosphere-approved-in-the-us-for-copd.html)
. [Last accessed: April 2026].

2.   AstraZeneca. Data On File. REF-325003.

3.   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.

4.   U.S. Centers for Disease Control and Prevention (CDC). Most Recent
Asthma Data.  Online . Available at:
https://www.cdc.gov/asthma-data/about/most-recent-asthma-data.html
(https://www.cdc.gov/asthma-data/about/most-recent-asthma-data.html) [Last
accessed: April 2026].

5.   Fernandes AG, et al. Risk factors for death in patients with severe
asthma. J Bras Pneumol. 2014;40(4):364-372.

6.   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.

7.   Buhl R, et al. One-year follow up of asthmatic patients newly initiated
on treatment with medium- or high-dose inhaled corticosteroid-long-acting
β2-agonist in UK primary care settings. Respir Med. 2020 Feb;162:105859.

8.   Global Asthma Network. The Global Asthma Report 2022.  Online .
Available
at: http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf
(http://globalasthmareport.org/resources/Global_Asthma_Report_2022.pdf) .
[Last accessed: April 2026].

9.   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
(https://clinicaltrials.gov/study/NCT04609878?limit=25&term=KALOS&rank=1)
. [Last accessed: April 2026].

10.  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
(https://clinicaltrials.gov/study/NCT04609904?limit=25&term=LOGOS&rank=4)
. [Last accessed: April 2026].

 

 

Matthew Bowden

Company Secretary

AstraZeneca PLC

 

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