FDA Approves Boehringer Ingelheim's Stiolto* Respimat As Once-Daily Maintenance Treatment For COPD

• Stiolto Respimat is the only COPD treatment with tiotropium, the active ingredient in Spiriva, complemented by olodaterol

Boehringer Ingelheim recently announced that the U.S. Food and Drug Administration (FDA) approved once-daily Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray. It has been approved as a long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Stiolto Respimat is not indicated to treat asthma or acute deterioration of COPD.

COPD, which includes chronic bronchitis and emphysema, is a serious but treatable lung disease, affecting 210 million people worldwide.¹ It is a growing world health priority and is predicted to become the 3rd leading cause of death by 2030.² Patients are typically diagnosed when lung function is already significantly impaired.³ COPD symptoms can negatively impact a patient’s ability to breathe especially when performing daily activities.⁴

“A recent review of landmark studies indicates that loss of lung function is more accelerated in the early stages of COPD.⁵ While no treatment slows the rate of decline, maintenance treatment with Stiolto Respimat initiated at the time of diagnosis will help healthcare providers with their goal of improving lung function,” said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc.

About Stiolto Respimat
“Stiolto Respimat produced greater lung function improvements in terms of FEV1 compared to tiotropium and olodaterol alone in patients with COPD across a range of severities (GOLD 2 to 4),”⁶,⁷,⁸said Richard Casaburi, MD, PhD, professor and associate chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center. “As a clinician, I am pleased to have a new treatment option to offer my patients.”

Tiotropium is a long-acting anticholinergic and the active ingredient in Spiriva Respimat and Spiriva HandiHaler. Since its approval more than 10 years ago, Spiriva has extensive clinical experience with over 40 million patient-years and more than 200 clinical trials. Spiriva is the most prescribed COPD maintenance treatment worldwide.

Olodaterol, marketed as Striverdi Respimat, is a long-acting beta2-agonist that was specifically designed to complement the efficacy of Spiriva. Olodaterol has a fast onset of action that has a clinically meaningful improvement in airflow five minutes after the first dose.

“The approval of Stiolto Respimat in the U.S. marks an important milestone in our ongoing commitment to provide effective solutions for patients with COPD,” said Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “Building on years of trusted experience with Spiriva, Stiolto, Respimat provides even further benefits than Spiriva alone and will offer a valuable new treatment option for patients and physicians. We look forward to the decision from the European regulatory authorities soon.”

The approval is based on data from the pivotal Phase III TONADO 1&2 trials (NCT01431274/NCT01431287), which evaluated more than 5,000 COPD patients and showed Stiolto Respimat provides statistically significant improvements in lung function over tiotropium and olodaterol alone.⁶ The trials, part of the TOviTO clinical trial programme involving more than 15,000 COPD patients worldwide, also showed Stiolto Respimat has a safety profile similar to tiotropium or olodaterol alone.⁶

About The Respimat Inhaler
Stiolto is administered via Respimat, the propellant-free, platform inhaler for Boehringer Ingelheim’s respiratory therapies, including approved and investigational therapies. Respimat is the only inhaler available that actively delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs.^9-15

Intended audiences
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales. For more information,visit www.boehringer-ingelheim.com.

*Expected brand name in Europe is Spiolto Respimat

¹WHO. Global Alliance Against Chronic Respiratory Diseases. Chronic Respiratory Diseases.

http://www.who.int/gard/publications/chronic_respiratory_diseases.pdf [Last accessed May 2015]

²WHO. Chronic respiratory diseases, Burden of COPD. http://www.who.int/respiratory/copd/burden/en/index.html [last accessed May 2015]

³Lindberg A, Bjerg-Backlund A, Ronmark E, Larsson L-G, Lundback B. Prevalence and underdiagnosis of COPD by disease severity and the attributable fraction of smoking Report from the Obstructive Lung Disease in Northern Sweden Studies. Respiratory Medicine. 2006;100:264-272.

⁴National Heart, Lung, and Blood Institute. What Is COPD? http://www.nhlbi.nih.gov/health/health-topics/topics/copd. Updated July 2013. Accessed April 23, 2015.

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¹¹Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. 2006:1(3) 251–259