a5163i
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 December 2020
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.
Trixeo Aerosphere
approved in the EU for COPD
14 December 2020 07:00 GMT
Trixeo
Aerosphere approved in the
EU for maintenance treatment of COPD
Fourth major approval for AstraZenecaÕs triple-combination
therapy
which is marketed as Breztri Aerosphere in the US, China and
Japan
AstraZenecaÕs Trixeo
Aerosphere (formoterol
fumarate/glycopyrronium bromide/budesonide) has been approved in
the European Union (EU) for maintenance treatment in adult patients
with moderate to severe chronic obstructive pulmonary disease
(COPD) who are not adequately treated by a combination of an
inhaled corticosteroid (ICS) and a long-acting beta2-agonist
(LABA), or a combination of a LABA and a long-acting muscarinic
antagonist (LAMA).
The approval by the European Commission was based on
positive results from the ETHOS Phase III trial in
which Trixeo
Aerosphere, a
triple-combination therapy, showed a statistically significant
reduction in the rate of moderate or severe exacerbations compared
with dual-combination therapies Bevespi
Aerosphere (glycopyrronium/formoterol fumarate) and
PT009 (budesonide/formoterol fumarate) over 52
weeks.1 The
approval was also supported by efficacy and safety data from the
KRONOS Phase III trial.2
Trixeo Aerosphere was recommended for
marketing authorisation by the Committee for Medicinal Products for
Human Use of the European Medicines Agency in October
2020.
COPD is a progressive disease, which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness and is the third leading cause of death
globally.3-6
Klaus Rabe, Professor of Pulmonary Medicine at the University of
Kiel, Director of the Department of Pneumology at Clinic
Grosshansdorf, Germany, and lead investigator of the ETHOS Phase
III trial, said: ÒChronic obstructive pulmonary disease
significantly contributes to morbidity and healthcare resource
utilisation in Europe. Even a single exacerbation can cause further
deterioration of a patientÕs lung function and increase the
risk of hospitalisation, so preventing exacerbations is a clinical
priority. Trixeo
Aerosphere has
demonstrated significant benefits in reducing exacerbations in
patients with moderate to severe disease, and triple-combination
therapy will play an increasingly important clinical role in
treating these patients.Ó
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: ÒTrixeo
Aerosphere has a strong
clinical profile compared with dual-combination therapies and
offers an important new treatment option for patients with chronic
obstructive pulmonary disease. In Europe, about one in 10
adults over the age of 40 has chronic obstructive pulmonary
disease, with prevalence increasing. We look forward to discussing
all-cause mortality data from the ETHOS Phase III trial with health
authorities.Ó
Results from the ETHOS Phase III trial were published
in The
New England Journal of Medicine in June 20201 and
results from the KRONOS Phase III trial were published
in The
Lancet Respiratory Medicine in September 2018.2 In
both trials, the safety and tolerability
of Trixeo
Aerosphere were consistent
with the profiles of the dual comparators.1,2
COPD
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.3,4,5 It
affects an estimated 384 million people7 and
is the third leading cause of death globally.6 In
Europe, approximately 10% of adults over the age of 40 have COPD,
with prevalence set to increase,8,9 significantly
contributing to morbidity3 and
healthcare resource utilisation.10 Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important treatment goals in the
management of COPD.3 A
single COPD exacerbation can have a negative impact on lung
function,11,12 quality
of life13 and
increase the risk of hospitalisation.14 Additionally,
even one COPD exacerbation that results in hospitalisation
increases the risk of death.15,16
ATHENA clinical trial programme
The ETHOS and KRONOS Phase III trials are part of
AstraZenecaÕs ATHENA Phase III clinical trial programme
for Trixeo
Aerosphere, which included more
than 15,500 patients globally across 11 trials.
ETHOS is a randomised, double-blinded, multi-centre,
parallel-group, 52-week Phase III trial to assess the efficacy and
safety of Trixeo
Aerosphere in symptomatic
patients with moderate to very severe COPD and a history of
exacerbation(s) in the previous year. The primary endpoint was the
rate of moderate or severe exacerbations.1 Results
were published in The
New England Journal of Medicine.1
KRONOS is a randomised, double-blinded, parallel-group, 24-week,
chronic-dosing, multi-centre Phase III trial to assess the efficacy
and safety of Trixeo
Aerosphere in patients
with moderate to very severe COPD regardless of whether or not they
had an exacerbation in the previous year. The primary endpoints
were lung function parameters.2 Results
were published in The
Lancet Respiratory Medicine.2
Trixeo Aerosphere
Trixeo Aerosphere (formoterol fumarate/glycopyrronium
bromide/budesonide) is a single-inhaler, fixed-dose
triple-combination of formoterol fumarate, a LABA, glycopyrronium
bromide, a LAMA, with budesonide, an ICS, and delivered in a
pressurised metered-dose inhaler.
Trixeo Aerosphere is
approved under the brand name Breztri
Aerosphere in Japan, China
and the US for patients with COPD.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology is one of AstraZenecaÕs three
therapy areas and is a key growth driver for the
Company.
Building on a 50-year heritage, AstraZeneca is an established
leader in respiratory care, across inhaled and biologic medicines.
AstraZeneca aims to transform the treatment of asthma and COPD by
eliminating preventable asthma attacks across all severities and
removing COPD as a leading cause of death through earlier
biology-led treatment. The CompanyÕs early respiratory
research is focused on emerging science involving immune
mechanisms, lung damage and abnormal cell-repair processes in
disease and neuronal dysfunction.
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas. The
CompanyÕs growing presence in immunology is focused on five
mid- to late-stage franchises with multi-disease potential in
rheumatology (including systemic lupus erythematosus), dermatology,
gastroenterology, and systemic eosinophilic-driven diseases.
AstraZenecaÕs ambition in immunology is to achieve disease
control and ultimately clinical remission in targeted immune-driven
diseases.
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas -
Oncology, Cardiovascular, Renal & Metabolism, and Respiratory
& Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit astrazeneca.com and
follow the Company on Twitter @AstraZeneca.
Contacts
For details on how to contact the Investor Relations Team, please
click here.
For Media contacts, click here.
References
1. Rabe KF, Martinez FJ, Ferguson
GT, et
al. Inhaled Triple Therapy at
Two Glucocorticoid Doses in Moderate-to-Very Severe
COPD. N Engl J
Med 2020; 383:
35-48.
2. Ferguson GT, Rabe KF, Martinez
FJ, et
al. Triple combination of
budesonide/glycopyrrolate /formoterol fumarate using co-suspension
delivery technology versus dual therapies in chronic obstructive
pulmonary disease (KRONOS): a double-blind, parallel-group,
randomised controlled trial. Lancet Respir
Med. 2018; 6:
747Ð758.
3.
GOLD. Global Strategy for the Diagnosis, Management and Prevention
of COPD, Global Initiative for Chronic Obstructive Lung Disease
(GOLD) 2020. [Online]. Available at: http://goldcopd.org. [Last
accessed: October 2020].
4. Laviolette L, Laveneziana P; ERS
Research Seminar Faculty. Dyspnoea: a multidimensional and
multidisciplinary approach. Eur Respir
J. 2014; 43 (6):
1750-1762.
5. May SM, Li JT. Burden of
chronic obstructive pulmonary disease: healthcare costs and
beyond. Allergy Asthma
Proc. 2015; 36 (1):
4-10.
6. World Health
Organization. The top 10 causes of death. 24 May 2018. Available
at:
https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death
[Last accessed: December 2020].
7. Adeloye D, Chua S, Lee
C, et
al. Global Health
Epidemiology Reference Group (GHERG). Global and regional estimates
of COPD prevalence: Systematic review and
meta-analysis. J Glob
Health. 2015; 5 (2):
020415.
8. European
lung white book. 2013. Chapter 13 Chronic obstructive pulmonary
disease. Available at: https://www.erswhitebook.org/chapters/chronic-obstructive-pulmonary-disease/ [Last
accessed: September 2020].
9. Rehman A, Hassali, MAA, Muhammad
SA, et
al. The economic burden of
chronic obstructive pulmonary disease (COPD) in Europe: results
from a systematic review of the
literature. Eur
J Health Econ 2020; 21:
181Ð194.
10. European
lung white book. 2013 publication. Chapter 2 The Economic Burden of
Lung Disease. Available at:
https://www.erswhitebook.org/chapters/the-economic-burden-of-lung-disease/
[Last accessed: October 2020].
11. Kerkhof M, Voorham J, Dorinsky
P, et
al. Association between COPD
exacerbations and lung function decline during maintenance
therapy. Thorax. 2020; 75 (9): 744-753.
12. Halpin DMG, Decramer M, Celli
BR, et
al. Effect of a single
exacerbation on decline in lung function in
COPD. Respiratory
Medicine 2017; 128:
85-91.
13. Roche N, Wedzicha JA,
Patalano F, et
al. COPD
exacerbations significantly impact quality of life as measured by
SGRQ-C total score: results from the FLAME
study. Eur
Resp J. 2017; 50 (Suppl
61): OA1487.
14. Rothnie KJ,
MŸllerov‡ H, Smeeth L, et
al. Natural History
of Chronic Obstructive Pulmonary Disease Exacerbations in a General
Practice-based Population with Chronic Obstructive Pulmonary
Disease. Am
Jour of Resp Crit Care Med. 2018; 198 (4):
464-471.
15. Ho TW, Tsai YJ, Ruan
SY, et
al.
In-Hospital and One-Year
Mortality and Their Predictors in Patients Hospitalized for
First-Ever Chronic Obstructive Pulmonary Disease Exacerbations: A
Nationwide Population-Based Study. PLOS ONE. 2014; 9 (12): e114866.
16. Suissa S, DellÕAniello S,
Ernst P. Long-term natural history of chronic obstructive pulmonary
disease: severe exacerbations and
mortality. Thorax. 2012; 67 (11): 957-63.
Adrian Kemp
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:
14 December
2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|