FDA approves new labelling for Stiolto Respimat in COPD.- Boehringer.

Boehringer announced that the FDA approved new labeling for Stiolto Respimat (tiotropium bromide & olodaterol) Inhalation Spray that includes data showing a meaningful reduction in COPD exacerbations driven by tiotropium, which is the active ingredient in Spiriva Respimat (tiotropium bromide) Inhalation Spray. The FDA also revised the indication for Stiolto Respimat, which is now approved for the treatment of patients with COPD, including chronic bronchitis and emphysema.

Previously, the Stiolto Respimat indication was for the treatment of airflow limitation in patients with COPD, including chronic bronchitis and emphysema. The revised language broadens the indication and illustrates that Stiolto Respimat does more than simply improve airflow.

The Stiolto Respimat label will be updated to include clinical trial data of Spiriva Respimat that shows a decrease in exacerbations, as well as data from the DYNAGITO trial, a 52-week study involving more than 7,800 people across a broad range of people living with COPD, comparing Stiolto Respimat to Spiriva Respimat in the reduction of COPD exacerbations.