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FDA Expands Spiriva Respimat Label
The FDA has approved Spiriva Respimat (tiotropium bromide, Boehringer Ingelheim), a steroid-free inhalation spray, for the long-term, once-daily maintenance treatment of asthma in patients 6 years of age and older. The agency approved the supplemental new drug application under a priority review designation.
Spiriva Respimat, which is delivered as two puffs once a day of 1.25 mcg per puff, is the only long-acting muscarinic antagonist (LAMA) product indicated for asthma. It was originally approved in September 2015 for the long-term, once-daily maintenance treatment of asthma in patients12 years of age and older.
The new approval was based on efficacy and safety data from the phase 2 and phase 3 UniTinA-asthma clinical development program, which included more than 6,000 patients worldwide, including 804 children (6 to 11 years of age).
More than 24 million people have asthma in the United States, including 6.3 million children younger than 18 years of age. Many children and adults continue to have uncontrolled asthma despite taking maintenance treatments. According to the Centers for Disease Control and Prevention, 50% of adults and more than 38% of children with asthma in the U.S. remain symptomatic despite maintenance treatment.
Source: Boehringer Ingelheim; February 16, 2017.