FDA expands indication of BI inhaler to include maintenance treatment of asthma

Spiriva Respimat--Courtesy of Boehringer Ingelheim

The only inhaler that administers a slow-moving mist to help respiratory patients inhale the medication is now FDA-approved for the long-term maintenance treatment of asthma, in addition to its previous indication to treat COPD.

The expanded indication for Boehringer Ingelheim's Spiriva Respimat adds a new type of medication to the antiasthma arsenal, known as long-acting muscarinic antagonists, as opposed to long-acting beta2 agonists.

"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," said Dr. William Busse, a professor of medicine at the University of Wisconsin School of Medicine and Public Health's division of allergy, pulmonary and critical care, in a statement. "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."

The approval was based on efficacy and safety clinical data from about 5,000 patients showing that the drug/device combination product was safe, along with improved lung function and symptoms of asthma compared with placebo.

Spiriva is indicated for people aged 12 and over and comes in two doses (a once-daily dose of 2.5 µg for asthma and a once-daily dose of 5 µg for the treatment of COPD). Both are delivered via two successive puffs.

BI says the Respimat inhaler delivers the active ingredient Tiotropium independent of inspiratory efforts. And the slow-moving mist helps patient inhalation. That's important because poor administration technique is known to plague drug-delivering asthma and COPD inhalers.  

Meanwhile, the company is rolling out its COPD inhaler Spiolto Respimat in Croatia, the U.K., Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain, and says it anticipates more European approvals soon.

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