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.
Tiotropium Respimat is part of a class of medicines called long-acting muscarinic antagonists (LAMA) and is the only one of its kind approved for asthma. It works differently from other treatment options by complementing other maintenance therapies (usually ICS/LABA) to open the airways, which helps people breathe better and reduces asthma attacks, also known as exacerbations.
“This FDA approval expands the US indication for tiotropium Respimat to a broad range of patients, including children, adolescents and adults in the US who may suffer from symptomatic asthma despite taking other maintenance therapies,” said Dr William Mezzanotte, vice president and head of respiratory medicine at Boehringer Ingelheim. “The expansive paediatric programme within the comprehensive UniTinA-asthma clinical trial programme, reflects the ongoing commitment of Boehringer Ingelheim to providing innovative solutions for children and adults living with asthma and other serious respiratory diseases.”
In the comprehensive, large-scale UniTinA-asthma clinical trial programme, tiotropium Respimat demonstrated proven efficacy and safety as an add-on therapy for children, adolescents and adults with asthma.
Tiotropium Respimat is delivered via Respimat, the only inhaler that actively delivers a propellant-free mist, meaning a person just needs to take a slow deep breath in for the medication to go deep into the lungs.
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.