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FDA approves Stiolto Respimat for treatment of COPD
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The FDA approved Stiolto Respimat for the once-daily maintenance treatment in patients with COPD as well as chronic bronchitis and emphysema, according to a Boehringer Ingelheim press release.
Stiolto Respimat (tiotropium bromide and olodaterol) is an inhalation spray intended to be used as a long-term, once-daily maintenance treatment of airflow obstruction.
The drug, however, is not indicated to treat asthma or acute deterioration of COPD.
The approval is based widely on data from the phase 3 TONADO trials, which evaluated more than 5,000 patients with COPD and indicated the drug significantly improved lung function over tiotropium and olodaterol alone.
“A recent review of landmark studies indicates that loss of lung function is more accelerated in the early stages of COPD,” Danny McBryan, MD, vice president, Clinical Development & Medical Affairs, Respiratory, Boehringer Ingelheim Pharmaceuticals, said in the release. “While no treatment slows the rate of decline, maintenance treatment with Stiolto Respimat initiated at the time of diagnosis will help health care providers with their goal of improving lung function.”