FDA approves Spiriva Respimat for asthma in adults, adolescents
The FDA approved Spiriva Respimat for the long-term, once-daily treatment of asthma in patients aged 12 years and older, according to a manufacturer press release.
“The [FDA] approval of Spiriva Respimat in asthma establishes a new class of inhaled asthma therapy and provides an efficacious, new option for patients,” William Mezzanotte, MD, MPH, head of respiratory medicine at Boehringer Ingelheim said in the release. “There is extensive clinical evidence demonstrating that Spiriva Respimat can improve outcomes for patients with asthma who remain symptomatic despite the use of [inhaled corticosteroids or long-acting beta2 agonist] maintenance therapy.”
The FDA approval stems from efficacy and safety data from 12 trials that included approximately 5,000 adults and adolescents with mild, moderate and severe symptomatic asthma who at least used an inhaled corticosteroid, according to the release.
Data indicated the addition of Spiriva Respimat (tiotropium bromide, Boehringer Ingelheim) improved lung function and reduced asthma exacerbations compared with placebo.
The approval is for a once-daily dose of 2.5 µg in patients with asthma. Spiriva Respimat is already approved for the treatment of COPD as a once-daily dose of 5 µg.
“In my clinical experience, some patients with uncontrolled asthma, despite treatment continue to experience symptoms, which can include coughing, wheezing, waking at night or shortness of breath,” William W. Busse, MD, a professor of medicine at University of Wisconsin School of Medicine and Public Health, said in the release. “For patients who continue to experience these symptoms, Spiriva Respimat is a once-daily maintenance treatment that has been shown to provide additional bronchodilation to help patients breathe better and reduce asthma attacks.”