INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim today announced that the U.S. 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).1 This approval reflects the comprehensive tiotropium Respimat® paediatric clinical trial programme, involving 905 children aged 6-11 years, conducted by Boehringer Ingelheim.2,3,4
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.1,5,6,7,8,9,10,11,12,13
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.14,15,16,17,18,19,20
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.1 Tiotropium Respimat® was approved in the EU in 2014 as an add-on therapy for adults (aged 18 and older) with asthma.
For more information please visit http://www.boehringer-ingelheim.com/press-release/ASTHMA-FDA-Expanded_Approval_of_Tiotropium_Respimat®
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products varies from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
SPIRIVA® Respimat® is currently NOT APPROVED for use in children and adolescents under 18 years of age in the EU. SPIRIVA® Respimat® has been approved for use in asthma in over 50 countries, including in the EU, U.S. and Japan. The label varies by country. Please refer to the local product information.
* Respimat® delivers a metered dose of medication in a mist at the push of a button not requiring the force from the patient’s inhalation