TIDMAZN
RNS Number : 6420E
AstraZeneca PLC
19 October 2018
19 October 2018 13:00 BST
CHMP issues a positive opinion for Bevespi Aerosphere
for the treatment of chronic obstructive pulmonary disease
AstraZeneca today announced 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-5r ), 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.
For more information, please visit http://www.astrazeneca.com/
and follow us on Twitter @AstraZeneca.
Media Relations
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Investor Relations
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AstraZeneca PLC
References
1. GOLD. Global Strategy for the Diagnosis, Management and
Prevention of COPD, Global Initiative for Chronic Obstructive Lung
Disease (GOLD) 2018. [Online]. Available at: http://goldcopd.org.
Last accessed: October 2018.
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. Clinicaltrials.gov. Efficacy and Safety of PT003, PT005, and
PT001 in Subjects With Moderate to Very Severe Chronic Obstructive
Pulmonary Disease (COPD); (PINNACLE 1). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01854645. Last accessed:
October 2018.
4. Clinicaltrials.gov. Multi-Center Study to Assess the Efficacy
and Safety of PT003, PT005, and PT001 in Subjects With Moderate to
Very Severe COPD (PINNACLE 2). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01854658. Last accessed:
October 2018.
5. AstraZeneca plc. Bevespi Aerosphere demonstrates
statistically significant improvement in lung function in patients
with COPD. [Online]. Available at:
https://www.astrazeneca.com/media-centre/press-releases/2017/bevespi-aerosphere-demonstrates-statistically-significant-improvement-in-lung-function-in-patients-with-copd-25092017.html
Last accessed: October 2018
6. Clinicaltrials.gov. Extension Study to Evaluate the Safety
and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate
to Very Severe COPD, With Spiriva(R) Handihaler(R) (PINNACLE 3).
[Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT01970878. Last accessed:
October 2018.
7. AstraZeneca. Aerosphere Delivery Technology - Global Core Claims Guide.
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END
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