NAPSR news: FDA approves Boehringer Ingelheim’s Striverdi Respimat to treat COPD

The approval of Stiverdi Respimat is another great achievement for Boehringer Ingelheim as they continuously expand on their respiratory product pipeline.
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WASHINGTON - Aug. 1, 2014 - PRLog -- The FDA has approved Boehringer’s Stiverdi Respimat (olodaterol) to treat chronic obstructive pulmonary disease (COPD) which encompasses chronic bronchitis and/or emphysema that are experiencing airflow obstruction. The drug is administered in the form of an inhalation spray used once daily over a long period of time.

"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."

Striverdi Respimat’s safety and effectiveness was evaluated involving 3,104 people diagnosed with COPD.  Clinical data obtained from the Phase III olodaterol clinical trial program—including data from 48-week and 6-week duration trials—revealed improvements in lung function compared to the placebo.

COPD, or chronic obstructive pulmonary (PULL-mun-ary) disease, is a progressive lung disease that makes it hard to breathe. Symptoms associated with COPD include coughing, producing large amounts of mucus, wheezing, shortness of breath. COPD’s known leading cause is that of cigarette smoke or prolonged exposure to cigarette smoke and/or other lung irritants such as air pollution, chemical fumes – even dust. COPD develops slowly and will worsen over time. According to the National Heart, Lung, and Blood Institute, COPD is the third leading cause of death in the United States. There is no known cure for COPD to date. “The availability of this new long-term maintenance medication provides an additional treatment options for the millions of Americans who suffer with COPD,” said Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.

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