FDA Approves Boehringer Ingelheim's Striverdi Respimat (olodaterol) Inhalation Spray for Maintenance Treatment of COPD
August 1, 2014
(Ridgefield, CN) – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved Striverdi® Respimat® (olodaterol) Inhalation Spray 5 mcg 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.
"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 mcg, 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.
About Striverdi® Respimat® (olodaterol) Inhalation Spray
Indication
Striverdi® Respimat® (olodaterol) Inhalation Spray is a long-acting beta2-agonist indicated for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Important Limitations: STRIVERDI RESPIMAT is not indicated to treat acute deteriorations of COPD and is not indicated to treat asthma.
About COPD
Chronic obstructive pulmonary disease (COPD) includes chronic bronchitis and emphysema. This disease makes it harder to breathe because less air is able to flow in and out of the lungs. As many as 26 million Americans may have COPD - even those who haven't smoked in years - and nearly half of them remain undiagnosed. COPD is the third leading cause of death in the United States, killing one person every four minutes. Globally, the incidence of COPD is expected to increase in the coming decades.
Common symptoms of COPD include shortness of breath and coughing with or without excess mucus. COPD develops slowly, is progressive and irreversible, and symptoms often worsen over time, limiting people's ability to perform routine activities.
Leading Respiratory Forward
Through research, treatments and patient-centric support services, the Boehringer Ingelheim (BI) lung health portfolio is designed to help address the challenges people living with a lung disease face every day. Leveraging the company's cutting edge science and leadership in chronic obstructive pulmonary disease (COPD), BI is researching new treatment approaches where needs persist. It is the company's goal to make a difference in the lives of patients with COPD, asthma, lung cancer, idiopathic pulmonary fibrosis and other respiratory diseases.
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.
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.
For more information please visit http://www.us.boehringer-ingelheim.com
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