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Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended that clinical data included in a new drug application (NDA) provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.1A,B,C
“We at Boehringer Ingelheim are pleased with the Advisory Committee’s recommendation and look forward to continuing to work with the FDA as the Agency continues its review of the olodaterol NDA,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “The positive vote from the Advisory Committee marks an important step towards making once-daily olodaterol, which is designed to add additional bronchodilation in combination with tiotropium, available to the estimated 210 million patients with COPD worldwide.2”
The Committee also voted affirmatively that data showing the efficacy and a positive safety profile of olodaterol supports approval of the 5g dose.3A,B
The Committee reviewed data from the Phase 3 olodaterol clinical trial programme, including data from the 48-week and 6-week duration trials. These data are part of the NDA being reviewed to establish that olodaterol delivered once-daily at the 5 յg dose showed improvements in lung function, as measured by forced expiratory volume in one second (FEV1), over at least 24 hours, in patients with moderate to very severe COPD compared to placebo and also active comparators.3A
The trials were conducted in a patient population representative of those seen in clinical practice.3A,C Overall olodaterol was well tolerated. The most commonly reported adverse reactions were nasopharyngitis, dizziness, rash, and arthralgia. Patients involved in the studies were allowed to continue on their usual care with the exception of long-acting beta agonists. Usual care included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthenes.3B,C
Olodaterol, delivered in the new generation inhaler Respimat Soft MistTM Inhaler, has been designed by Boehringer Ingelheim as a combination partner for tiotropium for the maintenance treatment of COPD.
Full results from the Phase 3 studies included in the olodaterol NDA will be presented at future medical meetings.4A
In addition to the 48-week and 6-week duration studies assessing the safety and efficacy of olodaterol, the Committee also reviewed a set of replicate studies evaluating the impact of olodaterol on exercise tolerance in COPD patients. This is the first time a company has sought inclusion of exercise tolerance data in a COPD product’s label.
“Patients with COPD often have impaired exercise tolerance because lung hyperinflation develops during exercise,” said Richard Casaburi, PhD, MD, Professor of Medicine, UCLA School of Medicine. “Improving exercise tolerance is a critical component of COPD management strategies.”
* Olodaterol is an investigational compound. Its safety and efficacy have not yet been fully established.
Notes to editors
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of death and disability throughout the world, and has a significant physical and emotional impact on those who suffer from the disease.5
As COPD progresses, lung function declines and physical activity may become severely limited, disrupting the patient’s ability to lead a full life, interfering with everyday tasks and participation in family routines.6 This can lead to people feeling afraid, anxious, frustrated, isolated and depressed.7
World Health Organisation (WHO) figures estimated that 210 million people are living with COPD.2 According to WHO more than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally.8 However, mortality data is likely to be significantly under-estimated due to under-recognition and under-diagnosis of COPD.7 WHO predicts that COPD will become the third leading cause of death worldwide by 2030.9
COPD patients often have other serious medical conditions, such as heart disease, diabetes, osteoporosis and depression – making treatment of COPD in parallel with these diseases even more difficult.10 Due to the chronic nature of the disease and its disabling symptoms, COPD can also represent a considerable burden on those who care for friends and relatives with the condition. Early diagnosis and intervention with appropriate treatment following an exacerbation is important to help patients recover more rapidly and improve their quality of life.11
Boehringer Ingelheim: Leading respiratory forward
The treatment of respiratory diseases has been a major area of focus for Boehringer Ingelheim for over 90 years and significant resources are dedicated to research in this therapy area.
Boehringer Ingelheim has a long heritage in the field of respiratory diseases, and developed Spirivaή, which is currently the most investigated and most prescribed once-daily maintenance prescription medicine for COPD. Boehringer Ingelheim has also branched out into developing treatment options for other airway diseases, including asthma, lung cancer and idiopathic pulmonary fibrosis.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
As a central element of its culture, Boehringer Ingelheim pledges to act in a socially responsible manner. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim’s endeavours.
In 2011, Boehringer Ingelheim achieved net sales of about €13.17 billion. R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.
For more information please visit www.boehringer-ingelheim.com
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1. U.S. Department Of Health And Human Services: Food and Drug Administration. “Pulmonary-Allergy Drugs Advisory Committee; Notice of Meeting.” November 20, 2012. Accessible at: http://www.ofr.gov/(S(lta0kjwb54ou0k0ehgw0lnop))/OFRUpload/OFRData/2012-28205_PI.pdf. Last retrieved on November 20, 2012.
a. Page 1, Paragraph 1, Lines 4-6
b. Page 1, “Date and Time”
c. Page 2, “Agenda,” Lines 1-5
2. World Health Organisation. Global surveillance, prevention and control of chronic respiratory diseases: A comprehensive approach. Available at: http://whqlibdoc.who.int/publications/2007/9789241563468_eng.pdf [accessed 22/01/13]
3. DOF. “Olodaterol Respimat Inhalation Spray.”
a. Slide CI-6
b. Slide CE-51
c. Slide CI-4, Lines 1-2
4. DOF. “Olodaterol / T+O Media Messages.”
a. Slide 7, “Message Track,” Bullet 3
5. Confronting COPD in America: Executive Summary. New York, NY:
6. Schulman, Ronca, and Bucuvalas Inc; 2001: 1-20. From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2011. Available at: http://www.goldcopd.org/ [accessed 22/01/13]
7. Maurer J , Rebbapragada B, Borsen S. et al. Anxiety and depression in COPD. Chest 2008; 134: 43S-56S.
8. World Health Organisation. Burden of COPD. Available at http://www.who.int/respiratory/copd/burden/en/index.html [accessed 22/01/13]
9. World Health Organisation. What is COPD. Available at: http://www.who.int/respiratory/copd/en/ [accessed 22/01/13]
10. Yawn BP, Kaplan A. Co-morbidities in people with COPD: a result of multiple diseases, or multiple manifestations of smoking and reactive inflammation? Prim Care Respir J 2008;17 (4):199-205
11. Wilkinson TMA, Donaldson GC, Hurst JR et al. Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 169: 1298-1303.