# AstraZeneca Plc CHMP issues a positive opinion for Bevespi Aerosphere

- Link: https://www.directorstalkinterviews.com/astrazeneca-plc-chmp-issues-a-positive-opinion-for-bevespi-aerosphere/412760248
- Published: 2018-10-19T13:28:59+01:00
- Author: Charlotte Edwards

**[AstraZeneca Plc](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l)**(
[LON:AZN](https://www.directorstalkinterviews.com/ftse-company/astrazeneca/azn.l))
announced today that the Committee for Medicinal Products for Human Use (CHMP) of
the European Medicines Agency has adopted a positive opinion, recommending the marketing
authorisation for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised
metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve
symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

The CHMP recommendation is based on the Phase III PINNACLE programme, which demonstrated
the efficacy and safety of Bevespi Aerosphere and involved more than 5,000 patients
with moderate to very severe COPD.

> **Dr Colin Reisner, Head of Respiratory, Global Medicines Development, said:**“
> Bevespi Aerosphere is the only fixed-dose long-acting muscarinic antagonist/long-
> acting beta2-agonist that is delivered in a pressurised metered-dose inhaler. 
> Today’s positive CHMP opinion means COPD patients in Europe are one step closer
> to having this new dual bronchodilator treatment available to them.”

Bevespi Aerosphere is approved in the US, Canada and Australia as a dual bronchodilator
for the long-term maintenance treatment of COPD.

**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 is predicted to be the third leading cause of death
by 2020.1,2 Improving lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important to the management of COPD.1

**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, compared to its monotherapy components(
glycopyrronium and formoterol fumarate) and to placebo.3,4,5 In PINNACLE 1, open-
label tiotropium was included as an active control.3 PINNACLE 3 was a multi-centre,
randomised, double-blinded, parallel-group, chronic-dosing, active-controlled, 28-
week safety extension trial of PINNACLE 1 and 2, which evaluated the long-term safety,
tolerability, and efficacy of Bevespi Aerosphere administered twice daily via a 
pMDI compared to its monotherapy components.6 All the trials were conducted in patients
with moderate to very severe COPD.

**About Bevespi Aerosphere**

Bevespi Aerosphere is a fixed-dose dual bronchodilator combining glycopyrronium,
a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting
beta2-agonist (LABA). Bevespi Aerosphere is the only LAMA/LABA 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 Aerosphere Delivery Technology
is also the platform for other potential new medicines including PT010, AstraZeneca’s
triple combination of budesonide/glycopyrronium/formoterol fumarate.

**About AstraZeneca in Respiratory Disease**

Respiratory disease is one of AstraZeneca’s main therapy areas, and the Company 
has a growing portfolio of medicines that reached more than 18 million patients 
in 2017. 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-5rɑ), approved for severe eosinophilic asthma and in development for severe
nasal polyposis, 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 is focused on addressing
underlying disease drivers focusing on the lung epithelium, lung immunity and lung
regeneration.

**About AstraZeneca**

AstraZeneca 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. AstraZeneca operates in over 100 countries and
its innovative medicines are used by millions of patients worldwide.

Share on: