The US Food and Drug Administration (FDA) has accepted to review Boehringer Ingelheim's new drug application (NDA) for Spiriva Respimat (tiotropium bromide) Inhalation Spray to treat asthma.
The drug is indicated 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) being evaluated to determine its efficacy and safety in treating asthma patients and is currently not approved for this indication.
The drug is approved for the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) and to reduce COPD exacerbations.
Boehringer Ingelheim Pharmaceuticals senior vice-president of Medicine & Regulatory Affairs Sabine Luik said: "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."
The NDA submission 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.
These trials 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.
All the trials 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.