FDA Extends Approval of Asthma Treatment to Children
The FDA has expanded the indication of Boehringer Ingelheim Pharmaceuticals’ Spiriva Respimat (tiotropium bromide).
The FDA has expanded the indication of Boehringer Ingelheim Pharmaceuticals’ Spiriva Respimat (tiotropium bromide). The long-term, once-daily treatment of asthma is now indicated for use in individuals 6 years and older.
Spiriva Respimat is a steroid-free treatment that is not intended to treat sudden asthma symptoms. The FDA approved Spiriva’s supplemental drug application under a priority review designation and was granted pediatric exclusivity based on clinical trials, which demonstrated the drug’s efficacy and safety in children.
Spiriva Respimat received initial FDA approval in September 2015 as a long-term, once-daily prescription treatment in individuals 12 years and older. The treatment is delivered in 2 puffs once a day, 1.25 mcg per puff.
“As health care providers, we need options like Spiriva Respimat, to consider as an add-on treatment to improve asthma symptoms for the broad age range of patients who may need more control,” Bradley E. Chipps, MD, Capital Allergy & Respiratory Disease Centers, said in a press release.
FDA Expands Approval of Spiriva Respimat (tiotropium bromide) inhalation spray for maintenance treatment of asthma in children [news release]. 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. Feb. 16, 2017.