FDA Accepts for Review the NDA for Boehringer Ingelheim's Spiriva Respimat Inhalation Spray for Asthma

Boehringer Ingelheim has 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.

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.

Tiotropium has been available in the US 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.