Spiriva Respimat Approved for Children 6 and Up

The US Food and Drug Administration (FDA) recently broadened the approval of Spiriva Respimat (tiotropium bromide; Boehringer Ingelheim) inhalation spray to include children 6 and older. The once-daily, steroid-free maintenance treatment for asthma was initially approved in September 2015 for patients 12 and older. 

“This FDA approval expands the indication of Spiriva Respimat to a broad range of people, including children, adolescents, and adults who may be experiencing uncontrolled asthma,” said Sabine Luik MD, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim.

Spiriva Respimat belongs to a class of drugs known as long-acting muscarinic antagonists and is the only medicine in its class approved for asthma. The long-term maintenance treatment is delivered as 2 puffs once a day, 1.25 mcg per puff. 

The inhaler operates independently of inspiratory effort, helping patients breathe the medicine into their lungs while minimizing inhalation effort, according to Boehringer Ingelheim. Inhalation duration should last at least 1.5 seconds. Maximum benefits may take 4 to 8 weeks to take effect.

The FDA approved the supplemental new drug application under priority review. Efficacy and safety data from the phase 2 and phase 3 UniTinA-asthma clinical development program spanned more than 150 sites around the world and included more than 6000 patients, 804 of whom were children between the ages of 6 and 11. The FDA also granted pediatric exclusivity to Spiriva Respimat.

Nearly 6.3 million children in the United States have asthma. In many, it is uncontrolled. More than 38% of American children with asthma remain symptomatic despite maintenance treatment according to the Centers for Disease Control and Prevention. 

“It is important for healthcare providers to identify and treat patients who may be taking a controller medicine, but who continue to experience uncontrolled asthma symptoms that can make it difficult to breathe and may even cause an exacerbation,” said Bradley E Chipps, MD, Capital Allergy & Respiratory Disease Center. 

“As health care providers, we need options, like Spiriva Respimat,” he said. —Jolynn Tumolo