New data reflect advancements across novel inhaled therapies, respiratory biologics and research into underlying disease pathways
AstraZeneca will demonstrate the breadth and depth of its industry-leading respiratory disease medicines with more than 60 abstracts and scientific presentations at the American Thoracic Society (ATS) 2016 International Conference in San Francisco, California, 13-18 May 2016.
Data support AstraZeneca’s novel inhaled combinations, precision medicines and innovative science, which targets new pathways in asthma and chronic obstructive pulmonary disease (COPD). Highlights include:
- 11 abstracts focused on BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate 9 mcg/4.8 mcg), recently approved by the US FDA, a novel fixed-dose dual bronchodilator pMDI utilizing AstraZeneca’s Co-Suspension Technology for the treatment of COPD. LABAs, such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. The most common adverse reactions with BEVESPI AEROSPHERE were urinary tract infection and cough. BEVESPI AEROSPHERE is not a rescue medication.
- Biomarker data on benralizumab, an anti–eosinophil monoclonal antibody currently in Phase III trials in both severe asthma and COPD. The data evaluate the potential for baseline serum biomarkers of the IL-13 pathway as well as high baseline blood eosinophils to predict treatment response. These data may be of value for both benralizumab and tralokinumab (IL-13 monoclonal antibody).
- Data highlighting breakthrough science aimed at addressing and potentially modifying the underlying causes of respiratory diseases, with a research focus on key biological pathways, including eosinophilic disease, Th2-driven disease and epithelial-driven pathobiology.
In addition, data will be presented evaluating the effects on lung function and airway inflammation of roflumilast, the oral PDE4 inhibitor, initiated in addition to standard therapy with corticosteroids and antibiotics at the onset of an acute exacerbation of COPD.
Tom Keith-Roach, Vice President, Global Product Strategy for Respiratory, Inflammation and Autoimmunity, said: “Respiratory is one of AstraZeneca’s main therapy areas and it’s exciting that the data being shared at ATS demonstrate how rapidly our pipeline and portfolio are developing. We believe that BEVESPI AEROSPHERE and investigational compounds, including benralizumab, will be important options for patients living with respiratory conditions worldwide.”
AstraZeneca key presentations at ATS 2016:
|Lead author||Abstract title||Presentation details|
BEVESPI AEROSPHERE (glycopyrrolate/formoterol fumarate)
|PINNACLE-1 & PINNACLE-2
|Pooled analyses from PINNACLE-1 and -2: the novel LAMA/LABA co-suspension technology glycopyrrolate/formoterol fixed-dose combination delivered by MDI shows improvement versus monocomponents in patients with COPD||Wednesday, 18 May, 9:00 AM
|Safety and efficacy of a novel LAMA/LABA co-suspension technology glycopyrrolate/formoterol fixed-dose combination delivered by MDI: Results of a one-year extension study in patients with COPD (PINNACLE-3)||Wednesday, 18 May, 9:00 AM
|Reisner C||24-hour lung function profile of novel co-suspension glycopyrrolate/formoterol metered dose inhaler versus placebo and Spiriva® Respimat®, in patients with moderate-to-very-severe chronic obstructive pulmonary disease||Wednesday, 18 May, 9:00 AM
|Arora S||24-hour lung function following the novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI, in patients with moderate-to-very-severe COPD||Wednesday, 18 May, 9:00 AM
|Martinez F||The novel LAMA/LABA co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI significantly improves health status in symptomatic patients with COPD||Wednesday, 18 May, 9:00 AM
|Mack P||Drug delivery from a novel LAMA/LABA
co-suspension technology of glycopyrrolate/formoterol fixed-dose combination MDI: Evidence of consistency, robustness and patient-use reliability
|Tuesday, 17 May, 9:00 AM
|Orevillo C||Pharmacokinetic and safety profile of a novel co-suspension technology fixed-dose combination of budesonide/glycopyrrolate/formoterol delivered by metered dose inhaler in healthy adult subjects||Wednesday, 18 May, 9:00 AM
|Newbold P||High blood eosinophil concentrations and serum biomarkers of low IL-13 pathway activation at baseline predict exacerbation rate reduction by benralizumab for patients with moderate to severe asthma||Monday, 16 May, 2:15 PM
|Ranade K||Dipeptidyl peptidase-4 (DPP-4) is a novel predictive biomarker for the investigational anti-IL13 targeted therapy tralokinumab||Monday, 16 May, 2:15 PM
Developments in Respiratory Science
|Ding B||A cross-sectional assessment of the burden of chronic obstructive pulmonary disease (COPD) symptoms in the United States and Europe using the National Health and Wellness Survey||Oral
Tuesday, 17 May, 2:15 PM
|Inoue H||Proportion and characteristics of asthma– chronic obstructive pulmonary disease (COPD) overlap syndrome among COPD patients in Japan||Late-Breaker Poster Discussion
Tuesday, 17 May, 2:15 PM-4:15 PM
|Miravitilles M||Efficacy of aclidinium/formoterol on bronchodilation and symptoms in symptomatic and asymptomatic patients with COPD: pooled analysis of two Phase III studies||Wednesday, 18 May 9:00 AM
|Singh D||Reduction in clinically important deterioration in chronic obstructive pulmonary disease in patients treated with aclidinium/formoterol combination||Wednesday, 18 May 9:00 AM
|Roflumilast initiated at onset of acute exacerbation of COPD enhances lung function recovery: results from the randomised, double-blind, placebo-controlled, parallel-group trial, Treatment with Roflumilast at ExAcerbaTion (TREAT)||Tuesday, 17 May 9:00 AM
|Reduction of airway inflammation with roflumilast initiated at onset of acute exacerbation of COPD: results from the randomised, double-blind, placebo-controlled, parallel-group trial, Treatment with Roflumilast at ExAcerbaTion (TREAT)||Tuesday, 17 May 9:00 AM
Emerging and Disease Modification Science
|Mardh CK||A novel inhaled non-steroidal modulator of inflammation for the control of asthma; AZD7594||Sunday, 15 May, 9:00 AM
|Jackson S||Safety and tolerability of AZD1419, an inhaled oligonucleotide-based toll-like receptor 9 agonist in healthy volunteers: a potential new therapy for asthma||Sunday, 15 May, 9:00 AM
|Goransson M||SIK inhibition: A novel opportunity to modulate disease phenotype in COPD||Tuesday, 17 May, 9:00 AM
BEVESPI AEROSPHERE is a combination of glycopyrrolate, an anticholinergic, and formoterol fumarate, a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. BEVESPI AEROSPHERE is not indicated for the relief of acute bronchospasm or for the treatment of asthma.INDICATION
Important Safety Information about BEVESPI AEROSPHERE, including Boxed WARNING
WARNING: Long-acting beta2-adrenergic agonists (LABAs), such as formoterol fumarate, one of the active ingredients in BEVESPI AEROSPHERE, increase the risk of asthma-related death. A placebo-controlled trial with another LABA (salmeterol) showed an increase in asthma-related deaths in subjects receiving salmeterol. This finding with salmeterol is considered a class effect of all LABAs, including formoterol fumarate. The safety and efficacy of BEVESPI AEROSPHERE in patients with asthma have not been established. BEVESPI AEROSPHERE is not indicated for the treatment of asthma.
All LABAs are contraindicated in patients with asthma without use of a long-term asthma control medication. BEVESPI is contraindicated in patients with a hypersensitivity to glycopyrrolate, formoterol fumarate, or to any component of the product.
BEVESPI should not be initiated in patients with acutely deteriorating COPD, which may be a life-threatening condition.
BEVESPI should not be used for the relief of acute symptoms, i.e., as rescue therapy for acute episodes of bronchospasm. Acute symptoms should be treated with an inhaled short-acting beta2-agonist.
BEVESPI should not be used more often or at higher doses than recommended, or with other LABAs, as an overdose may result.
If paradoxical bronchospasm occurs, discontinue BEVESPI immediately and institute alternative therapy.
If immediate hypersensitivity reactions, including angioedema, urticaria, or skin rash, occur, discontinue BEVESPI at once and consider alternative treatment.
BEVESPI can produce a clinically significant cardiovascular effect in some patients, as measured by increases in pulse rate, blood pressure, or symptoms. If such effects occur, BEVESPI may need to be discontinued.
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines.
Be alert to hypokalemia and hyperglycemia.
Worsening of narrow-angle glaucoma or urinary retention may occur. Use with caution in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction and instruct patients to contact a physician immediately if symptoms occur.
The most common adverse reactions with BEVESPI (≥2% and more common than placebo) were: cough, 4.0% (2.7%), and urinary tract infection, 2.6% (2.3%).
Use caution if administering adrenergic drugs because the sympathetic effects of formoterol may be potentiated.
Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of formoterol.
Use with caution in patients taking non–potassium-sparing diuretics, as the ECG changes and/or hypokalemia may worsen with concomitant beta2-agonists.
The action of adrenergic agonists on the cardiovascular system may be potentiated by monoamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval. Therefore BEVESPI should be used with extreme caution in patients being treated with these agents.
Use beta-blockers with caution as they not only block the therapeutic effects of beta-agonists, but may produce severe bronchospasm in patients with COPD.
Avoid co-administration of BEVESPI with other anticholinergic-containing drugs as this may lead to an increase in anticholinergic adverse effects.
NOTES TO EDITORS
Asthma is a common, chronic condition in which inflammation and narrowing of the airways may cause wheezing, breathlessness, chest tightness and coughing. Despite current and available treatment options, asthma continues to effect the health and day-to-day lifestyles of more than 300 million children, men and women worldwide. By 2020, asthma will likely increase in numbers to affect as many as 400 million people.
Systemic steroid exposure can lead to serious adverse effects, including osteoporosis, anxiety, depression, weight gain and diabetes. There is also a significant physical and socio-economic burden of asthma with severe asthma accounting for 50% of intangible asthma related health costs.
COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD.
About Respiratory, Inflammation and Autoimmunity Diseases
Respiratory, Inflammation and Autoimmunity (RIA) is one of AstraZeneca’s main therapy areas. Our strong pipeline has the potential to deliver up to seven launches between 2016 and 2020. In respiratory disease, our aim is to transform asthma and COPD treatment through inhaled combinations at the core of care; precision biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our unique Co-Suspension Technology.
In Inflammation and Autoimmunity, our aim is to develop innovative therapies for the treatment of autoimmune and rheumatoid diseases, with a lead program in systemic lupus erythematosus. Across respiratory, inflammation and autoimmune diseases, our research is focused on four key biological pathways: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology, and autoimmunity.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca-us.com.
|Abigail Bozarth||US||+1 302 885 2677|
|Lindsey Trickett||Oncology, CVMD||+1 240 543 7970|
|Mitch Chan||Oncology||+1 240 477 3771|
|Dial / Toll-Free||+1 866 381 7277|
Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,
ING - Infection, Neuroscience and Gastrointestinal
3252305 Last Updated 5/16