Spiriva Respimat filed with FDA for Asthma-Boehringer

Boehringer announced that the FDA accepted for review the New Drug Application (NDA) for Spiriva Respimat (tiotropium bromide) Inhalation Spray for the long-term, once-daily, add-on maintenance treatment of Asthma in patients 12 years of age and older who remain symptomatic on at least inhaled corticosteroids (ICS). Spiriva Respimat is a long-acting muscarinic antagonist (LAMA) currently being studied to determine its efficacy and safety in treating asthma patients and is not currently approved for this indication.

The NDA submission package for tiotropium in asthma is based on data from the UniTinA-asthma clinical trial program, including data from the pivotal PrimoTinA-, MezzoTinA- and RubaTinA-asthma studies, which evaluated tiotropium delivered via the Respimat inhaler as add-on treatment for adults and adolescents with moderate to severe asthma who continued to experience symptoms despite maintenance treatment with at least ICS. These studies are part of the Company's Phase III UniTinA-asthma clinical trial program, which includes several studies investigating tiotropium in asthma patients across a range of ages and disease severities. The UniTinA-asthma program includes more than 6,000 adult, adolescent and pediatric asthma patients in more than 150 sites globally.