New Indication Approval: Boehringer Ingelheim’s asthma drug, Spiriva Respimat

Boehringer Ingelheim has announced that the US Food and Drug Administration (FDA) approved tiotropium Respimat (marketed as Spiriva Respimat) for the long-term, once-daily maintenance treatment of people with asthma aged 6 years and older who continue to experience symptoms despite their other maintenance therapy – usually either inhaled corticosteroid (ICS) alone, or a combination of inhaled corticosteroids/long-acting beta agonists (ICS/LABA).

This approval reflects the comprehensive tiotropium Respimat paediatric clinical trial programme, involving 905 children aged 6-11 years, conducted by Boehringer Ingelheim.

Previously, in September 2015, tiotropium Respimat was approved in the US for the long-term, once-daily, prescription maintenance treatment of asthma in people aged 12 and older. Tiotropium Respimat was approved in the EU in 2014 as an add-on therapy for adults (aged 18 and older) with asthma.