The FDA has approved Boehringer Ingelheim’s sNDA for the use of Spiriva Respimat to treat asthma in patients aged 6 and older and has granted pediatric exclusivity for the product, the company announced. Spiriva Respimat was approved for the treatment of asthma in patients 12 and older in the US in September 2015.
Boehringer Ingelheim Pharmaceuticals Senior VP, Medicine & Regulatory Affairs Sabine Luik commented, “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. For nearly a century, Boehringer Ingelheim has been focused on addressing serious unmet needs. This approval is further evidence of our ongoing commitment to improving the lives of the patients we serve.”
The sNDA was approved under a priority review.
Read the Boehringer Ingelheim press release.
