FDA: Spiriva Respimat Granted Pediatric Exclusivity

The FDA has approved Spiriva Respimat for long-term, once-daily maintenance treatment of asthma in individuals aged 6 and older. Spiriva Respimat was approved in September 2015 for the maintenance treatment of asthma in individuals 12 years and older, and now has been granted pediatric exclusivity by the FDA.

Spiriva Respimat is a long-acting muscarinic antagonist, and is steroid-free. It is not a treatment for sudden asthma symptoms.

The approval is based on data from phase II and phase III UniTinA-asthma clinical development programs that determined the efficacy and safety of Spiriva Respimat in 6000 patients, included 804 children 6 to 11 years old. 

Common adverse events associated with Spiriva Respimat were sore throat, headache, bronchitis, and sinus infection.

— Melissa Weiss

Reference:

Boehringer Ingelheim Pharmaceuticals, Inc. FDA expands approval of Spiriva Respimat (tiotropium bromide) inhalation spray for maintenance treatment of asthma in children [press release]. Ridgefield, Connecticut: PRNewswire; February 16, 2017. http://www.prnewswire.com/news-releases/fda-expands-approval-of-spiriva-respimat-tiotropium-bromide-inhalation-spray-for-maintenance-treatment-of-asthma-in-children-300408750.html.