FDA Approves STIOLTO RESPIMAT Inhalation Spray for COPD

Boehringer Ingelheim has announced that the FDA has 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. More than 15 million Americans have been told that they have COPD, but as many as 45 percent of the total estimated COPD cases in the U.S. remain undiagnosed. Patients are typically diagnosed when lung function is already significantly impaired. COPD symptoms can negatively impact a patient's ability to breathe especially when performing daily activities.


"A recent review of landmark studies indicates that loss of lung function is more accelerated in the early stages of COPD. While no treatment slows the rate of decline, maintenance treatment with STIOLTO RESPIMAT initiated at the time of diagnosis will improve lung function," said Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, Inc. Lung function was measured by trough FEV1i and FEV1AUC0-3hii. 


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