New advance in COPD maintenance treatment, Spiolto® Respimat®, approved in first European countries

  • Spiolto® Respimat® is built on tiotropium, the active ingredient in Spiriva®, enhanced by olodaterol
  • Spiolto® Respimat® provides significant improvements in lung function, COPD symptoms, quality of life and rescue medication use over Spiriva® right from the initial stages when patients need maintenance therapy1
  • Spiolto® Respimat® more than doubles lung function* improvement over Spiriva® in patients who had no prior maintenance therapy2,3

Ingelheim, Germany, 2nd July, 2015 — Boehringer Ingelheim today announced regulatory authority approvals for Spiolto® Respimat® (tiotropium/olodaterol) in first European countries†. Spiolto® Respimat® is a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). Approvals of the treatment in other European countries are expected to follow in the coming months. Spiolto® Respimat® provides significant improvements in lung function, breathlessness, quality of life and rescue medication use over Spiriva® right from the initial stages when patients need maintenance therapy.1 These additional benefits could enable patients to remain active and avoid the downward spiral of COPD for as long as possible.

COPD is a chronic, progressive, treatable but incurable lung disease that affects 210 million people worldwide4 and is predicted to become the 3rd leading cause of death by 2030.5 Patients are typically diagnosed when lung function is already significantly impaired and maintenance therapy is needed.6They suffer from symptoms including breathlessness and coughing that often stop them from being active. This can lead to a downward spiral of worsening symptoms and even further inactivity,7contributing to an increased risk of disability and death.8
"The additional benefits gained from Spiolto® Respimat® compared to Spiriva® are significant for patients and data show the lung function benefits are even greater when used in the initial stages of COPD. It is a promising new therapeutic advance in COPD," said Roland Buhl, Professor of Medicine and Head of the Pulmonary Department at Mainz University Hospital. "Optimal management right from the start of maintenance therapy may give patients with this highly debilitating lung disease, the best opportunity to stay active, manage their symptoms and have a better quality of life."

TOviTO wheel

TOviTO wheel

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The national regulatory approvals, following finalisation of the decentralised European regulatory procedure on 20th May, are based on data from the >5,000 patient TONADO® 1&2 clinical trials. The TONADO® trials are part of the >15,000 patient TOviTO® clinical trial programme which shows Spiolto® Respimat® provides clinically relevant improvements over Spiriva®‡:

  • Significant improvement in lung function*, with greatest benefit seen in patients who are at the first stage of needing maintenance therapy for their COPD3 – and more than double the improvement in lung function* in patients who had no prior maintenance therapy§ (148ml vs. 72ml)2
  • Reduction in breathlessness and less use of rescue medication among patients1 (22% and 26% improvement in use of daytime and night-time rescue medication over Spiriva® respectively)
  • More patients experiencing noticeable improvements in their quality of life (57.5% vs 48.7%)1
  • Spiolto® Respimat® was well tolerated with a safety profile that was similar to tiotropium or olodaterol alone1

"Since its first launch in 2002, Spiriva® has brought medical benefits that have made a real difference to the lives of millions of patients with COPD around the world. Spiolto® Respimat® is our newest advance in COPD treatment. Its recent approval in the US**, Canada and Australia, alongside the approval in countries across Europe, is an important step forward in our ongoing commitment to provide effective solutions for patients with COPD," said Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "We anticipate further approvals of Spiolto® Respimat® in other European countries over the coming months."

Spiolto® Respimat® is built on tiotropium, the active ingredient in Spiriva® - the world's most prescribed COPD maintenance treatment with over 40 million patient years of real life experience across all COPD severities.9 It is enhanced by olodaterol††, a unique and effective long-acting beta2-agonist with a fast onset of action, specifically designed to complement the efficacy of Spiriva®. Spiolto® is delivered by Respimat®, the only inhaler available that actively‡‡ delivers a unique mist, meaning the patient just needs to breathe in naturally for the medication to go deep into the lungs.10-16

For further information:

For further information visit http://newscentre.boehringer-ingelheim.com/

Notes to Editors

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 may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is 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, such as the initiative "Making more Health" and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

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

____________________________________________

* Improvement in trough FEV1 after 24 weeks of treatment
† As of Monday 29th June, Spiolto® Respimat® has been approved in Croatia, United Kingdom, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain 
‡ The data in this press release refer to Spiolto® Respimat® 5/5µg dose which is the dose approved by regulatory authorities
§ Patients without prior maintenance therapy at baseline
**Registered as Stiolto™ Respimat® in the US
†† Marketed as Striverdi® Respimat®
‡‡ 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 Buhl R, Maltais F, Abrahams R, et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD2-4). Eur Respir J 2015; 45(4):969-79.
2 Buhl R, Abrahams R, Grönke L, et al. Tiotropium Plus Olodaterol Fixed-Dose Combination Therapy Provides Lung Function Benefits when Compared with Tiotropium Alone, Irrespective of Prior Treatment with a Long-Acting Bronchodilator: Post Hoc Analyses Of Two 1-Year Studies. ATS 2015 congress Abstract 64799.
3 Ferguson GT, et al. Efficacy of tiotropium + olodaterol in patients with COPD by initial disease severity and treatment intensity. Adv Ther 2015 Jun 26. [Epub ahead of print]
4 WHO. Global Alliance Against Chronic Respiratory Diseases. Chronic Respiratory Diseases.  http://www.who.int/gard/publications/chronic_respiratory_diseases.pdf [Last accessed June 2015]
5 WHO. Chronic respiratory diseases, Burden of COPD. http://www.who.int/respiratory/copd/burden/en/index.html.
6 Mapel DW, et al. Severity of COPD at initial spirometry-confirmed diagnosis: data from medical charts and administrative claims. Int J COPD 2011; 6: 573–581.
7 Reardon JZ, Lareau SC, ZuWallack R. Functional status and quality of life in chronic obstructive pulmonary disease. Am J Med 2006; 119(10 Suppl 1):32-37.
8 Casaburi R. Activity promotion: a paradigm shift for chronic obstructive pulmonary disease therapeutics. Am Thorac Soc 2011; 8(4):334-337.
9 BI data on file.
10 Newman SP, Brown J, Steed KP, Reader SJ, Kladders H. 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.
11 Pitcairn G, Reader S, Pavia D, Newman S. 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.
12 Peterson JB, Prisk GK, Darquenne C. 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.
13 Dalby R, Spallek M, Voshaar T. A review of the development of Respimat® Soft Mist™ Inhaler. Int J Pharm 2004;283:1-9.
14 Zierenberg B. Optimising the in vitro performance of the Respimat®. J Aerosol Med 1999;12 (Suppl 1): S19-S24.
15 Dalby RN, Eicher J, Zierenberg B. Development of Respimat® SoftMist™ inhaler and its clinical utility in respiratory disorders. Med Devices (Auckl) 2011;4:145-155.
16 Anderson P. Use of Respimat Soft Mist Inhaler in COPD patients. Int J Chron Obstruct Pulmon Dis.  2006;1(3): 251–259.

 

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