FDA expands indication for Boehringer Ingelheim’s Spiriva Respimat

SILVER SPRING, Md. — The Food and Drug Administration has approved an expanded indication for Boehringer Ingelheim Pharmaceuticals’ Spiriva Respimat (tiotropium bromide), the company announced Thursday. 

 

The asthma maintenance treatment is now indicated for children ages 6 years and older. It had previously been approved as an asthma treatment for adults and adolescents. 

 

“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,” Boehringer Ingelheim SVP medicine and regulatory affairs Dr. Sabine Luik  said. “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.”