TIDMAZN
RNS Number : 4474C
AstraZeneca PLC
19 October 2020
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 people
(6) 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 life(11) 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
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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
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