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 October 2020
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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by check mark whether the registrant files or will file annual
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Trixeo Aerosphere receives positive CHMP opinion
19 October 2020 07:00 BST
Trixeo
Aerosphere recommended for
approval in the EU
by CHMP for the maintenance treatment of COPD
Recommendation of triple-combination therapy based on
positive results from ETHOS and KRONOS Phase III
trials
AstraZeneca's Trixeo Aerosphere (formoterol
fumarate/glycopyrronium bromide/budesonide) has been recommended
for marketing authorisation 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
long-acting beta2-agonist (LABA), or a combination of a LABA and a
long-acting muscarinic antagonist.
Trixeo Aerosphere, a
triple-combination therapy, is approved under the brand
name Breztri
Aerosphere in Japan, China
and the US for patients with COPD.
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the ETHOS Phase III trial in which Trixeo
Aerosphere 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 recommendation for approval was also supported by data from the
KRONOS Phase III trial.2 In
both trials, the safety and tolerability
of Trixeo
Aerosphere were consistent
with the profiles of the dual comparators.1,2
Klaus Rabe, Professor of Pulmonary Medicine at the University of
Kiel, Director of the Department of Pneumology at Clinic
Grosshansdorf, Germany, Lead Investigator of the ETHOS trial and
National Co-ordinating Investigator of the KRONOS Phase III trial,
said: "Preventing exacerbations is central to the management of
chronic obstructive pulmonary disease, as exacerbations may cause
irreversible damage and disease progression. The triple-combination
therapy, Trixeo
Aerosphere, has
demonstrated significant benefits in reducing moderate or severe
exacerbations in patients suffering from this debilitating
disease."
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&D, said: "Chronic obstructive pulmonary disease is now the
third leading cause of death globally and affects approximately one
in 10 adults over the age of 40 in Europe. Trixeo
Aerosphere has
demonstrated strong clinical benefit when compared with
dual-combination therapies and this positive recommendation brings
us closer to providing a much-needed new treatment to patients in
Europe."
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 people6 and
is the third leading cause of death globally.7 In
Europe, approximately 10% of adults over the age of 40 have
COPD.8 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,9,10 quality
of life11 and
increase the risk of hospitalisation.12 Additionally,
even one COPD exacerbation that results in hospitalisation
increases the risk of death.13,14
ATHENA clinical trial programme
The ETHOS and KRONOS Phase III trials are part of AstraZeneca's
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 AstraZeneca's 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 Company's 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 Company's 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.
AstraZeneca's 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:
747-758.
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. 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.
7. Quaderi SA, Hurst JR.
The unmet global burden of COPD. Glob
Health Epidemiol Genom. 2018; 3: e4.
Published 2018 Apr 6. doi:10.1017/gheg.2018.1.
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: October 2020].
9. 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.
10. 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.
11. 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.
12. Rothnie KJ,
Müllerová H, Smeeth L, Quint JK. 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.
13. 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.
14. Suissa S, Dell'Aniello 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:
19 October 2020
|
By: /s/
Adrian Kemp
|
|
Name:
Adrian Kemp
|
|
Title:
Company Secretary
|
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