Boehringer Ingelheim Announces FDA Approval of New Inhalation Spray Striverdi®Respimat®

August 9, 2014

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Striverdi®Respimat® (olodaterol) Inhalation Spray 5 µg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma. STRIVERDI RESPIMAT is a long-acting beta agonist (LABA) delivered via a propellant-free inhaler that generates a soft, slow-moving mist.

“The approval of STRIVERDI RESPIMAT marks another step forward for our diverse respiratory pipeline that includes other compounds being evaluated using the Respimat® inhaler,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Boehringer Ingelheim has been a leading provider of treatments for people living with COPD for more than a decade, and we are continuing to investigate therapies that may provide additional benefits, including a Phase III program evaluating a fixed-dose combination of olodaterol and tiotropium.”

The approval of STRIVERDI RESPIMAT is supported by data from the Phase III olodaterol clinical trial program—including data from 48-week and 6-week duration trials—that demonstrated improvements in lung function provided by the once-daily dosing of olodaterol 5 µg, as measured by forced expiratory volume in one second (FEV1), in patients with moderate to very severe COPD compared to placebo. The olodaterol Phase III clinical trial program involved more than 4,900 people living with COPD. In an effort to more accurately represent the clinical practice setting, patients involved in the 48-week studies were allowed to continue on their usual care with the exception of LABAs. Usual care included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthines.

“In clinical practice, many COPD patients are likely to be on more than one therapy to treat airflow obstruction,” said Richard Casaburi, MD, PhD, Professor and Associate Chief, Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center. “The Boehringer Ingelheim studies with olodaterol are important from a clinical perspective because they provide confirmation of bronchodilation even when patients are taking other medications.”

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About Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 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.

Social responsibility is a central element of Boehringer Ingelheim’s culture. 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 endeavors.

In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.

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