# AstraZeneca’s Breztri Aerosphere approved in the US for COPD

- Link: https://www.directorstalkinterviews.com/astrazenecas-breztri-aerosphere-approved-in-the-us-for-copd/412845057
- Published: 2020-07-24T07:23:01+01:00
- Author: Amilia Stone

**[AstraZeneca plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
_Breztri_ _Aerosphere_ has been approved in the US for the maintenance treatment
of patients with chronic obstructive pulmonary disease (COPD).

The approval by the US Food and Drug Administration (FDA) was based on positive 
results from the Phase III ETHOS trial in which _Breztri 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_(
glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate).^(
1) The approval was also supported by efficacy and safety data from the Phase III
KRONOS trial.^(2)

> **Dr. Fernando J. Martinez, Chief of Division of Pulmonary and Critical Care Medicine
> at Weill Cornell Medicine and New York-Presbyterian Weill Cornell Medical Center,
> New York, US and Investigator in the ETHOS trial, said:** “Preventing exacerbations
> is central to the management of chronic obstructive pulmonary disease. Even a 
> single exacerbation can have a negative impact on a patient’s lung function and
> quality of life, and it can increase the risk of death. _Breztri_ _Aerosphere_
> has demonstrated significant benefits in reducing exacerbations in patients suffering
> from COPD.”

> **Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said:** “_Breztri
> Aerosphere_ has demonstrated a strong clinical profile compared with dual-combination
> therapies and offers a meaningful new treatment option for patients. Chronic obstructive
> pulmonary disease is a debilitating progressive condition and the fourth leading
> cause of death in the US. We look forward to discussing all-cause mortality data
> from the _Breztri Aerosphere_ ETHOS trial with health authorities.”

Results from the Phase III ETHOS trial were published in The New England Journal
of Medicine^(1) in June 2020 and results from the Phase III KRONOS trial were published
in The_Lancet Respiratory Medicine_ in September 2018.^(2) In both trials, the safety
and tolerability of _Breztri Aerosphere_ were consistent with the profiles of the
dual comparators.^(1,2)

_Breztri Aerosphere_ is not indicated for the relief of acute bronchospasm or for
the treatment of asthma in the US or other countries. _Breztri Aerosphere _is approved
in Japan and China for patients with COPD and under regulatory review in the EU.

**Financial considerations**

Under the terms of the past agreement to acquire Pearl Therapeutics Inc., AstraZeneca
will make a $150m milestone payment upon US regulatory approval of _Breztri Aerosphere_
for COPD. This is the final development and regulatory milestone under that agreement.

**COPD**

COPD is a progressive disease which can cause obstruction of airflow in the lungs
resulting in debilitating bouts of breathlessness.^(3 )It affects an estimated 384
million people^(4) and is the third leading cause of death globally.^(5) Improving
lung function, reducing exacerbations and managing daily symptoms such as breathlessness
are important treatment goals in the management of COPD.^(3) Even a single COPD 
exacerbation may be associated with a significant increase in the rate of decline
in lung function,^(6) a significant deterioration in quality of life,^(7) and can
significantly reduce life expectancy and increase the risk of mortality.^(8,9)

**ETHOS, KRONOS and the ATHENA clinical trial programme**

ETHOS is a randomised, double-blinded, multi-centre, parallel-group, 52-week trial
to assess the efficacy and safety of _Breztri 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)

KRONOS is a randomised, double-blinded, parallel-group, 24-week, chronic-dosing,
multi-centre trial to assess the efficacy and safety of _Breztri 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)

ETHOS and KRONOS are part of AstraZeneca’s ATHENA Phase III clinical trial programme
for _Breztri Aerosphere_, which included more than 15,500 patients globally across
11 trials.

**Breztri Aerosphere**

_Breztri Aerosphere_ (budesonide/glycopyrrolate/formoterol fumarate) is a single-
inhaler, fixed dose triple-combination of budesonide, an inhaled corticosteroid (
ICS), with glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol
fumarate, a long-acting beta2-agonist (LABA), delivered in a pressurised metered-
dose inhaler.

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