Boehringer files NDA at FDA for olodaterol + tiotropium for COPD

Boehringer Ingelheim has announced that the 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.