FDA approves sNDA for Stiolto Respimat

The FDA has approved labeling and indication changes for Boehringer Ingelheim’s Stiolto Respimat tiotropium/olodaterol SMI, adding data about reductions in COPD exacerbations to the label. Stiolto Respimat (marketed in Europe as Spiolto Respimat) was initially approved in the US in 2015, with the indication limited to the treatment of airflow limitation in COPD patients. In March 2016, the FDA approved an sNDA adding quality of life data to the label.

Earlier this year, the company announced data from the DYNAGITO study that showed a 7% greater reduction in moderate-to-severe COPD exacerbations compared to Spiriva Respimat.

Boehringer Ingelheim Senior VP of Medicine and Regulatory Affairs Thomas Seck said, “This approval adds comprehensive data to the label of Stiolto Respimat, giving healthcare providers and those living with COPD important information about how the medicine can help reduce the risk of a COPD exacerbation. Boehringer Ingelheim is dedicated to advancing our clinical research program to help people living with chronic, debilitating respiratory diseases, such as COPD, better manage their conditions.”

Read the Boehringer Ingelheim press release.