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 April 2026
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Breztri
approved in the US for asthma
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 320/36/9.6lg) 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 (320/18/9.6lg) 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 were published
in The
Lancet Respiratory Medicine 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
(FEV1)
area under the curve 0 to 3 hours (AUC0-3)
at Week 24 and trough FEV1 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
FEV1 AUC0-3 at
week 24, and the key secondary endpoint was change from baseline in
morning pre-dose trough FEV1 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
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 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. 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.
[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 [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 b2-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.
[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.
[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. [Last
accessed: April 2026].
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: 28 April
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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