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news.Boehringer Ingelheim has received approval from the US Food and Drug Administration (FDA) for once-daily Stiolto Respimat inhalation spray, as a long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
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The company said that Stiolto Respimat (tiotropium bromide and olodaterol) is not indicated to treat asthma or acute deterioration of COPD, which is a serious but treatable lung disease.
Tiotropium is a long-acting anticholinergic and the active ingredient in Spiriva Respimat and Spiriva HandiHaler.
Around 210 million people across the world are affected by COPD, which includes chronic bronchitis and emphysema.
Boehringer Ingelheim Pharmaceuticals Clinical Development & Medical Affairs, Respiratory vice-president Danny McBryan said: "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."
The FDA approval is based on data from the pivotal Phase III TONADO 1 and 2 trials (NCT01431274/NCT01431287), which evaluated more than 5,000 COPD patients and showed Stiolto Respimat provides statistically significant improvements in lung function over tiotropium and olodaterol alone.
The trials, which are part of the TOviTO clinical trial program involving over 15,000 COPD patients across the world, also showed Stiolto Respimat has a safety profile similar to tiotropium or olodaterol alone.