Jamie Barrand | Sep 18, 2015

Spriva Respimat approved by FDA for maintenance treatment of asthma

The U.S. Food and Drug Administration (FDA) this week approved Boehringer Ingelheim Pharmaceuticals, Inc.'s  Spiriva Respimat product as a long-term, once-daily, prescription maintenance treatment of asthma in patients 12 and older.

More than 22 million people in the United States deal with asthma, which can make breathing difficult as a patient’s airways to become inflamed and tighten. 

Spiriva Respimat's FDA approval establishes a new class of asthma medication, long-acting muscarinic antagonists (LAMAs).

"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,” Dr. William Busse, professor of medicine for the Division of Allergy, Pulmonary and Critical Care at the University of Wisconsin School of Medicine and Public Health, said. “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.”

A comprehensive clinical trial was conducted before the FDA gave approval for Spiriva Respimat. The study included 12 trials including approximately 5,000 adults and adolescents with mild, moderate and severe symptomatic asthma.

Data showed Spiriva Respimat significantly improved lung function and reduced exacerbations for asthma patients.

Common side effects noted were sore throat, sinus infections, bronchitis and headache.

“For nearly a century, Boehringer Ingelheim has been dedicated to discovering medicines for serious respiratory diseases, such as asthma,” Dr. Sabine Luik, senior vice president of Medicine & Regulatory Affairs at Boehringer Ingelheim, said. “As an industry leader in respiratory, it is our goal to develop new medicines that help address unmet needs. This FDA approval enhances asthma therapy by providing health care providers and patients with a new class of treatment to consider.”

The FDA already had approved Spiriva Respimat for the long-term, once-daily maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema, and to reduce exacerbations in COPD patients.

For more information about Spiriva Respimat, visit www.us.boehringer-ingelheim.com.

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