Dive Brief:
- Boehringer Ingelheim (BI) has filed an NDA for Spiriva Respimat (tiotropium bromide) Inhalation Spray for the treatment of asthma in patients 12 and older who have already tried corticosteroids.
- Spiriva Respimat is currently indicated for the treatment of bronchospasm in patients with chronic obstructive pulmonary disease (COPD).
- The drug is a long-acting muscarinic antagonist (LAMA).
Dive Insight:
In September, BI published a press release directed to media outside of the U.S., the UK, and Canada highlighting clinical data showing that, in patients with asthma, Spiriva Respimat reduces the risk of severe asthma exacerbations by 21% (when used as add-on therapy in patients whose symptoms are not controlled on their current therapies).
Approval of Spiriva Respimat would represent the introduction of an entirely new class of inhaled treatment for asthma—and the first new inhaled treatment in more than 10 years.