BRIEF—FDA approves Stiolto Respimat sNDA

Boehringer Ingelheim announced today that the US Food and Drug Administration has approved new labeling for Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray that includes data showing a meaningful reduction in chronic obstructive pulmonary disease (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.