US FDA Expands Approval of Tiotropium Respimat® for Maintenance Treatment of Asthma in Children
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
Media + PR
Dr. Kristin Jakobs
Phone: +49 6132 77 144553
Mobile: +49 1516 89 47444
Fax: +49 6132 77 6601
Information om Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco
Følg pressemeddelelser fra Business Wire
Skrive dig op her og du vil løbende modtage pressemeddelelser på mail. Indtast din mail, klik på abonner og følg instruktionerne i den udsendte mail.
Flere pressemeddelelser fra Business Wire
TAN-DELTA23.11.2017 14:40 | pressemeddelelse
Tan Delta: New Oil Condition Monitoring Kit for Gas Engine Operators Reduces Daily Operating Costs, Improves Equipment Efficiency and Extends Equipment Life.
INSTITUT-CURIE23.11.2017 14:02 | pressemeddelelse
Making Institut Curie a Reference for Technology Transfer in Oncology
WEALTH-DYNAMIX23.11.2017 09:02 | pressemeddelelse
Wealth Dynamix (WDX) Ranks No.18 in the 2017 Tech Track 100 by the Sunday Times and 19th Fastest Growing Technology Company in the UK in the 2017 Deloitte Technology Fast 50
MOBIDIAG-LTD23.11.2017 08:02 | pressemeddelelse
Mobidiag Signs Agreement with Interlux for the Distribution of Amplidiag® Diagnostic Tests and Instruments in Estonia
OCP-S.A.22.11.2017 18:01 | pressemeddelelse
OCP Announces Date of 2017 Third Quarter and Nine Month Results
TATA-MOTORS22.11.2017 15:48 | pressemeddelelse
Tata Motors Charts Out 'Connecting Aspirations' As Its New Corporate Brand Identity in Global Markets
I vores nyhedsrum kan du læse alle vores pressemeddelelser, tilgå materiale i form af billeder og dokumenter, og finde vores kontaktoplysninger.Besøg vores nyhedsrum