The FDA has accepted Boehringer Ingelheim’s new drug application for the fixed-dose combination (FDC) of tiotropium and olodaterol delivered via the Respimat inhaler for the proposed indication of long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. The product will not be indicated to treat acute deteriorations of COPD or to treat asthma.
This FDC is an investigational treatment and is being evaluated for once-daily use via the Respimat inhaler, a propellant-free inhaler that generates a slow-moving mist.
“The FDA’s acceptance of our application for the fixed-dose combination of tiotropium and olodaterol is an important milestone for our company, and it reinforces Boehringer Ingelheim’s steadfast commitment to COPD,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs.
The submission for the tiotropium and olodaterol FDC follows several long-term studies of the drugs as part of a larger clinical trial.