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Boehringer Ingelheim. (2/16/17). "Press Release: US FDA Expands Approval of Tiotropium Respimat for Maintenance Treatment of Asthma in Children". Ingelheim.

Region Region United States (USA)
Organisations Organisation Boehringer Ingelheim (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product Spiriva®
  Product 2 Respimat® Soft Mist Inhaler (SMI)
     


> Tiotropium Respimat® (marketed as SPIRIVA® Respimat®) now approved in US as asthma maintenance treatment for people aged 6 years and older

> FDA approval expands use of tiotropium Respimat® in the US to a broad age range of people across all asthma severities

> Tiotropium Respimat® is currently NOT APPROVED for use in children and adolescents with asthma outside of the US


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.


About Asthma

Asthma is one of the most common conditions in childhood.21 There are fewer treatment options in paediatric asthma than in adult asthma.22

Asthma is not conquered. Almost 1 in 2 patients remain symptomatic despite their current maintenance therapies (usually ICS/LABA).23,24,25 These symptoms have a detrimental effect on their work, education, sleep, social life and relationships.26 Additionally, symptoms increase their risk of potentially fatal asthma attacks in the next few weeks by up to six times.27

For more information please see the latest infographic.


Boehringer Ingelheim

Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates presently with a total of some 50,000 employees worldwide. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.

In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.

For more information please visit www.boehringer-ingelheim.com


Intended audiences:

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.


Footnotes

* Note: 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


References

1 US Prescribing Information. SPIRIVA Respimat. Boehringer Ingelheim. 2017. Data on file
2 Efficacy and safety of 2 doses of tiotropium Respimat compared to placebo in children with moderate persistent asthma. Accessed January 20, 2017, from https://clinicaltrials.gov/ct2/show/NCT01634139
3 Efficacy and Safety of 2 Doses of Tiotropium Respimat® Compared to Placebo in Children With Severe Persistent Asthma. (n.d.). Accessed January 20, 2017, from https://clinicaltrials.gov/ct2/show/NCT01634152
4 A Study to Evaluate Efficacy and Safety of Tiotropium in Children 6 to 11 Years Old With Moderate Asthma. Accessed Feburary 6 2017, from https://clinicaltrials.gov/ct2/show/NCT01383499
5 Kerstjens HAM, Engel M, Dahl R et al. Tiotropium in asthma poorly controlled with standard combination therapy. N Engl J Med 2012;367(13): 1198-1207.
6 Goldstein S, Szefler S, Vogelberg C, et al. Once-daily tiotropium Respimat® Add-on Therapy Improves FEF25–75% in Children and Adolescent Patients with Persistent Symptomatic Asthma. ATS 2016 International Conference
7 Szefler S, Harper III T, Laki I, et al. Once-daily tiotropium Respimat® Add-on Therapy Improves Lung Function in Children with Severe Symptomatic Asthma. ATS 2016 International Conference.
8 Schmidt O, Hamelmann E, Vogelberg C, Laki I, El Azzi G, Engel M, et al. Once-daily tiotropium Respimat® add-on therapy improves lung function in children with moderate symptomatic asthma. Abstract presented at the ERS International Congress 2016, London, 3 – 7 September, 2016.
9 Vogelberg C, Laki I, Schmidt O, Hamelmann E, El Azzi G, Engel M, et al. Safety and tolerability of once-daily tiotropium Respimat® add-on therapy in children with moderate symptomatic asthma. Abstract presented at the ERS International Congress 2016, London, 3 – 7 September, 2016.
10 Hamelmann E, Vogelberg C, Bernstein JA, Harper III T, Moroni-Zentgraf P, Engel M, et al. Once-daily tiotropium Respimat® add-on therapy improves PEF in participants aged 6-17 years with symptomatic asthma. Poster presented at the ERS International Congress 2016, London, 3 – 7 September, 2016.
11 Vogelberg C, Szefler SJ, Hamelmann E, Boner A, Moroni-Zentgraf P, Engel M, et al. Safety of tiotropium Respimat® add-on therapy in patients aged 6–17 years with symptomatic asthma. Poster presented at the ERS International Congress 2016, London, 3 – 7 September, 2016.
12 Bisgaard H, Vandewalker M, Granham L, Moroni-Zentgraf P, Engel M, El Azzi G, et al. Safety of tiotropium in pre-school children with symptomatic persistent asthma. Abstract presented at the ERS International Congress 2016, London, 3 – 7 September, 2016
13 Szefler S, Rupp N, Boner A, et al. Safety and Tolerability of Once-daily tiotropium Respimat® Add-on Therapy in Children with Severe Symptomatic Asthma. ATS 2016 International Conference
14 Newman SP, et al. Lung deposition of fenoterol and flunisolide delivered using a novel device for inhaled medicines: Comparison of Respimat® with conventional metered-dose inhalers with and without spacer devices. Chest, 1998;113:957-963.
15 Pitcairn G, et al. Deposition of corticosteroid aerosol in the human lung by Respimat® Soft Mist™ Inhaler compared to deposition by metered dose inhaler or by Turbuhaler® dry powder inhaler. J Aerosol Med. 2005;18(3):264-272
16 Peterson JB, et al. Aerosol deposition in the human lung periphery is increased by reduced-density gas breathing. J Aerosol Med Pulm Drug Deliv. 2008;21(2):159–168.
17 Dalby R, et al. A review of the development of Respimat® Soft Mist™
Inhaler. Int J Pharm. 2004; 283:1-9.
18 Zierenberg B. Optimising the in vitro performance of the Respimat®. J Aerosol Med. 1999;12(Suppl 1):S19-S24
19 Dalby RN, et al. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl). 2011;4:145-155.
20 Anderson P. Use of Respimat® Soft Mist™ Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis. 2006:1(3)251–259.
21 WHO. Asthma. Available from http://www.who.int/mediacentre/factsheets/fs307/en/ (accessed January 2017).
22 Bush A, et al. Pharmacological treatment of severe, therapy-resistant asthma in children: what can we learn from where? European Respiratory Journal. 2011 38: 947-958.
23 Bateman ED, Boushey HA, Bousquet J, et al. GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004; 170 (8): 836-44.
24 Partridge MR, Dal Negro RW, Olivieri D, et al. Understanding patients with asthma and COPD: insights from a European study. Prim Care Respir J 2011; 20 (3): 315-323.
25 Demoly P, Paggiaro P, Plaza V, et al. Prevalence of asthma control among adults in France, Germany, Italy, Spain and the UK. Eur Respir Rev 2009; 18: (112): 105–112.
26 Kantar Health. A shadow at work. An international survey among people with asthma. 2015.
27 Bateman ED, Reddel HK, Eriksson G, et al. Overall asthma control: the relationship between current control and future risk. J Allergy Clin Immunol. 2010;125(3):600-8.


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Record changed: 2023-06-05

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