Asthma Indication Sought for COPD Treatment
The FDA is reviewing a regulatory application to add an asthma indication to Boehringer Ingelheim's chronic obstructive pulmonary disease treatment, tiotropium bromide.
The FDA is reviewing a regulatory application to add an asthma indication to Boehringer Ingelheim’s chronic obstructive pulmonary disease (COPD) treatment, tiotropium bromide (Spiriva Respimat).
“There is a critical need for a new treatment option to provide benefits to, and improve outcomes for, patients with asthma,” said Klaus Dugi, chief medical officer for Boehringer Ingelheim, in a press release. “The FDA’s acceptance of our application brings us a step closer to providing a potential new treatment option for use as an add-on to maintenance treatment.”
Approved by the FDA in September 2014 for the maintenance treatment of COPD, Spiriva Respirmat Inhalation Spray is a long-acting muscarinic antagonist currently being studied to determine its efficacy and safety as a long-term, once-daily, add-on maintenance asthma treatment in patients aged 12 years and older who remain symptomatic on inhaled corticosteroids.
The regulatory submission package for tiotropium’s use in asthma is based on data from the phase 3 UniTinA-asthma clinical trial program, which includes several studies investigating the drug in more than 6000 adult, adolescent, and pediatric asthma patients with a range of disease severities.
“Boehringer Ingelheim is committed to addressing the unmet medical needs of patients with a variety of respiratory conditions,” said Sabine Luik, MD, the company’s senior vice president of medicine and regulatory affairs, in a separate press release. “We look forward to further discussions with the FDA about the potential use of Spiriva Respirmat in asthma.”
The most common adverse reactions to Spiriva Respirmat treatment in the placebo-controlled trials were pharyngitis, cough, dry mouth, and sinusitis.