Boehringer Ingelheim announces FDA acceptance of NDA filing for tiotropium and olodaterol FDC

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) 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 chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Tiotropium + olodaterol FDC will not be indicated to treat acute deteriorations of COPD or to treat asthma.

Tiotropium + olodaterol FDC is an investigational treatment consisting of the long-acting muscarinic antagonist (LAMA) tiotropium and the long-acting beta agonist (LABA) olodaterol, and is being evaluated for once-daily use via the Respimat® inhaler. The Respimat® inhaler is 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, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

The NDA submission for tiotropium + olodaterol FDC is based on results from three global Phase III trials – the 52-week replicate TONADO® 1&2 studies (NCT01431274/NCT01431287) and the 6-week cross-over VIVACITO® study (NCT01559116). The TONADO® 1&2 studies evaluated the long-term effect of tiotropium + olodaterol FDC on lung function, while VIVACITO® investigated the 24-hour bronchodilator profile of two tiotropium + olodaterol dose combinations. These studies are part of a large Phase III clinical trial program (TOviTO®) for tiotropium + olodaterol FDC, which includes more than 7,000 people living with varying severities of COPD worldwide.

Tiotropium monotherapy, which is marketed as Spiriva® HandiHaler® (tiotropium bromide inhalation powder) in the U.S., is a once-daily LAMA indicated for both the maintenance treatment of bronchospasm (narrowing of the airways) associated with COPD and to reduce COPD exacerbations. Olodaterol monotherapy—marketed as Striverdi® Respimat® (olodaterol) Inhalation Spray—is a once-daily LABA indicated for the long-term maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.


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