New Drug Application for Inhalation Spray for the Treatment of Asthma

Boehringer Ingelheim recently announced that the U.S. Food and Drug Administration (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.

SPIRIVA RESPIMAT is approved for the maintenance treatment of bronchospasm (narrowing of the airways) associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.

“Boehringer Ingelheim is committed to addressing the unmet medical needs of patients with a variety of respiratory conditions. We look forward to further discussions with the FDA about the potential use of SPIRIVA RESPIMAT in asthma,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

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- (NCT00772538/NCT00776984), MezzoTinA- (NCT01172808/NCT01172821) and RubaTinA-asthma (NCT01257230) 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 comprehensive 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.

Tiotropium has been available in the U.S. for more than ten years for the maintenance treatment of COPD under the brand name Spiriva HandiHaler (tiotropium bromide inhalation powder). The FDA approved SPIRIVA RESPIMAT for the treatment of COPD in September 2014. SPIRIVA RESPIMAT provides a pre-measured amount of medicine in a slow-moving mist that helps patients inhale the medicine. The Respimat inhaler was developed to actively deliver medication in a way that does not depend on how fast air is breathed in from the inhaler.

SPIRIVA RESPIMAT (tiotropium bromide) Inhalation Spray is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema, and for reducing COPD exacerbations.

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