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2019-12-23

AstraZeneca: AstraZeneca's triple-combination therapy approved in China for patients with COPD

First fixed-dose triple-combination therapy in a pressurised
metered-dose inhaler device in China

Budesonide/glycopyrronium/formoterol fumarate is known as PT010
outside of China and as Breztri Aerosphere in Japan

AstraZeneca today announced that budesonide/glycopyrronium/formoterol
fumarate has been approved in China for the maintenance treatment of
chronic obstructive pulmonary disease (COPD).

This is the first approval by the National Medical Products
Administration for a triple-combination therapy in a pressurised
metered-dose inhaler (pMDI), which uses the innovative Aerosphere
delivery technology.

The approval follows a priority review and is based on results from
the Phase III KRONOS trial in which PT010 demonstrated a
statistically significant improvement in trough forced expiratory
volume in one second (FEV1), the primary endpoint for China, compared
with dual-combination therapies Bevespi Aerosphere
(glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol
fumarate).

The safety and tolerability of PT010 were consistent with the known
profiles of the dual comparators. Data from the KRONOS trial were
published in The Lancet Respiratory Medicine
(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30327-8/fulltext)
in October 2018.

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:
"Chronic obstructive pulmonary disease affects almost 100 million
people in China, and is a leading cause of morbidity and mortality.
With this approval, we are now able to provide a powerful new
triple-combination therapy to patients for whom new treatments are
critically needed. Our triple-combination therapy is administered in
a pressurised metered-dose inhaler, an important device option for
clinicians and patients in China."

Professor Wang Chen, Director of China National Clinical Research
Centre for Respiratory Diseases, Director of the Centre for
Respiratory Disease at China-Japan Friendship Hospital, and China
National Lead Investigator of the KRONOS trial, said: "Addressing the
burden of chronic obstructive pulmonary disease in China is a public
health priority and triple-combination therapy will play an important
role in helping patients manage their disease. In the KRONOS trial,
budesonide/glycopyrronium/formoterol fumarate provided rapid and
sustained lung function improvements in patients with
moderate-to-very-severe disease."

Budesonide/glycopyrronium/formoterol fumarate was approved in Japan
(https://www.astrazeneca.com/media-centre/press-releases/2019/breztri-aer...)
in June 2019 as Breztri Aerosphere, a triple-combination therapy to
relieve symptoms of COPD. The medicine is also under regulatory
review in the US and EU, under the name PT010.

About COPD

COPD is a progressive disease which can cause obstruction of airflow
in the lungs resulting in debilitating bouts of breathlessness.[1] It
affects an estimated 384 million people worldwide and approximately
100 million people in China.[2,3] COPD is predicted to be the third
leading cause of death globally by 2020.[1] Improving lung function,
reducing exacerbations and managing daily symptoms such as
breathlessness are important treatment goals in the management of
COPD.[1]

About ATHENA

ATHENA is AstraZeneca's Phase III global clinical trial programme for
PT010, including 11 completed trials with more than 15,500
patients.[4,5,6,7 ]The four key trials are ETHOS, KRONOS, TELOS and
SOPHOS.[4,5,6,7] The ETHOS and KRONOS trials assessed the efficacy
and safety of PT010.[4,5] The TELOS and SOPHOS trials characterised
PT009 and substantiated it as an active comparator in the PT010
clinical trial programme.[6,7]

In the KRONOS Phase III randomised, double-blinded, parallel-group,
24-week, chronic-dosing, multi-centre trial, PT010 met six of seven
lung function primary endpoints versus dual-combination therapies
Bevespi Aerosphere, Symbicort Turbuhaler (budesonide/formoterol
fumarate) and PT009 in patients with moderate-to-very-severe COPD, in
a patient population without a requirement for an exacerbation in the
previous year.[5] PT009 also met two non-inferiority endpoints to
support its qualification as an active comparator. As published in
The Lancet Respiratory Medicine
(https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30327-8/fulltext),
in a key secondary endpoint, PT010 showed a statistically significant
52% reduction in the rate of moderate or severe COPD exacerbations
compared with Bevespi Aerosphere.[5]

In the ETHOS Phase III randomised, double-blinded, multi-centre,
parallel-group, 52-week trial, PT010 demonstrated a statistically
significant reduction in the rate of moderate or severe exacerbations
compared with dual-combination therapies Bevespi Aerosphere and PT009
in patients with moderate-to-very-severe COPD and a history of
exacerbation(s) in the previous year.[4 ]Full trial design details
are published in Respiratory Medicine
(https://www.resmedjournal.com/article/S0954-6111(19)30267-7/fulltext).[8]
AstraZeneca announced
(https://www.astrazeneca.com/media-centre/press-releases/2019/breztri-aer...)
results from the Phase III ETHOS trial in August 2019.[9]

Bevespi Aerosphere is a fixed-dose dual bronchodilator in a pMDI,
combining glycopyrronium, a long-acting muscarinic antagonist (LAMA),
and formoterol fumarate, a long-acting beta2-agonist (LABA).
Symbicort Turbuhaler is a single inhaler containing budesonide, an
inhaled corticosteroid (ICS), and formoterol, a LABA. PT009 is a
single inhaler, fixed-dose dual-combination therapy of budesonide, an
ICS, and formoterol fumarate, a LABA.

About PT010

PT010 is a single-inhaler, fixed-dose triple-combination of
budesonide, an ICS, with glycopyrronium, a LAMA, and formoterol
fumarate, a LABA. The China approval for PT010 follows a priority
review designated for treatments that utilise advanced dosage
technology, innovative treatment measures or clinical treatment
advantage.

Under the terms of the agreement to acquire Pearl Therapeutics Inc.,
AstraZeneca anticipates making a $150m milestone payment upon US
regulatory approval of PT010 for COPD. This payment would be the
final development and regulatory milestone under that agreement.

About AstraZeneca in respiratory diseases

Respiratory is one of AstraZeneca's main therapy areas, and our
medicines reached more than 18 million patients as maintenance
therapy in 2018. AstraZeneca's aim is to transform asthma and COPD
treatment through inhaled combinations at the core of care, biologics
for the unmet needs of specific patient populations, and scientific
advancements in disease modification.

The Company is building on a 40-year heritage in respiratory disease
and AstraZeneca's capability in inhalation technology spans
pressurised metered-dose inhalers and dry powder inhalers, as well as
the Aerosphere delivery technology. The company also has a growing
portfolio of respiratory biologics including Fasenra
(anti-eosinophil, anti-IL-5R alpha), and tezepelumab (anti-TSLP)
which has been granted Breakthrough Therapy Designation by the US
Food and Drug Administration in patients with severe asthma and is in
Phase III trials. AstraZeneca's research aims at addressing
underlying disease drivers by focusing on the lung epithelium, lung
immunity, lung regeneration and neuronal functions.

About AstraZeneca

AstraZeneca (LSE/STO/NYSE: 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 and Metabolism, and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are used
by millions of patients worldwide. Please visit astrazeneca.com
(http://www.astrazeneca.com/) and follow the Company on Twitter
@AstraZeneca (https://twitter.com/AstraZeneca).

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References

1. 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: December 2019].

2. 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.

3. Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, et al. Prevalence and
risk factors of chronic obstructive pulmonary disease in China (the
China Pulmonary Health [CPH] study): a national cross-sectional
study. Lancet. 2018;391:1706-1717.

4. Clinicaltrials.gov. Study to Assess the Efficacy and Safety of
PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very
Severe COPD (ETHOS). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT02465567. [Last accessed:
December 2019].

5. Ferguson GT, Rabe KF, Martinez FJ, et al. Triple combination of
budesonide/glycopyrrolate /formo...

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