Posted by Michael Wonder on 13 Oct 2018
FDA approves Stiolto Respimat supplemental new drug application to add data on COPD exacerbation reduction
11 October 2018 - Stiolto Respimat is the first in its class to have exacerbation data in the product labelling.
Boehringer Ingelheim announced today that the U.S. FDA approved new labelling 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. Stiolto Respimat is a combination medicine that includes tiotropium.
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.
