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

Published on August 21, 2014 at 6:48 AM · No Comments

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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