# AstraZeneca PLC Bevespi Aerosphere approved by the Japanese

- Link: https://www.directorstalkinterviews.com/astrazeneca-plc-bevespi-aerosphere-approved-by-the-japanese/412785461
- Published: 2019-06-19T07:27:31+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))
today announced that Bevespi Aerosphere has been approved in Japan as a fixed-dose,
long-acting dual bronchodilator to relieve symptoms in patients with chronic obstructive
pulmonary disease.

This is the first approval by the Japanese Ministry of Health, Labour and Welfare
for a maintenance fixed-dose, long-acting dual bronchodilator in a pressurised metered-
dose inhaler (pMDI), which uses the innovative _Aerosphere_ delivery technology.

The approval was based on positive results from the Phase III PINNACLE 4 trial,^(
1) which demonstrated the efficacy and safety _of Bevespi Aerosphere_ in 1,756 patients
with moderate to very severe COPD across Asia, Europe and the US, as well as the
broader PINNACLE clinical programme involving more than 5,000 patients.^(2,3,4)

> **Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said**: “As
> the first medicine in its class to be approved in a pressurised metered-dose inhaler
> in Japan, _Bevespi Aerosphere_ offers an important new treatment option and choice
> of inhaler device for patients with moderate to very severe chronic obstructive
> pulmonary disease.”

_Bevespi Aerosphere _is already approved in the US, EU, Canada, Australia and other
countries as a dual bronchodilator for the maintenance treatment of moderate to 
very severe COPD.

**About **_**Bevespi Aerosphere**_

_Bevespi Aerosphere_ (glycopyrronium/formoterol fumarate) 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). Pressurised metered-
dose inhalers are an important choice for COPD patients where limited lung function,
advanced age and reduced dexterity or cognition are significant considerations for
patients to achieve therapeutic benefits from their medicines.^(5,6) _Bevespi Aerosphere_
is the only LABA/LAMA with _Aerosphere_ delivery technology. Results from an imaging
trial have shown that _Bevespi Aerosphere_ effectively delivers medicine to both
the large and small airways.^(7)

**About the Phase III PINNACLE programme**

PINNACLE 1, 2 and 4 were randomised, double-blinded, multi-centre, placebo-controlled
trials conducted over 24 weeks, which compared the efficacy and safety of _Bevespi
Aerosphere_ administered twice daily via a pMDI to its monotherapy components (glycopyrronium
and formoterol fumarate) and to placebo.^(1,2,3) In PINNACLE 1, open-label tiotropium
was included as an active control.^(2) PINNACLE 3 was a multi-centre, randomised,
double-blinded, parallel-group, chronic-dosing, active-controlled, 28-week safety
extension trial of PINNACLE 1/2, which evaluated the long-term safety, tolerability
and efficacy of _Bevespi Aerosphere_ administered twice daily via a pMDI compared
to its monotherapy components.^(4) All the trials were conducted in patients with
moderate to very severe COPD.

**About COPD**

COPD is a progressive disease which can cause obstruction of airflow in the lungs
resulting in debilitating bouts of breathlessness.^(8) It affects an estimated 384
million people worldwide and is predicted to be the third leading cause of death
by 2020.^(8,9) Improving lung function, reducing exacerbations and managing daily
symptoms such as breathlessness are important treatment goals in the management 
of COPD.^(8)

**About AstraZeneca in respiratory disease**

Respiratory is one of AstraZeneca’s three 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), now approved for severe, eosinophilic asthma and 
in development for severe nasal polyposis and other potential indications, 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.

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