Tuesday, October 22, 2013

New once-daily Striverdi* (olodaterol) Respimat® gains approval in first EU countries

INGELHEIM, Germany - Friday, October 18th 2013 [ME NewsWire]

    Phase III trials have shown that once-daily Striverdi® Respimat® provided fast, remarkable and sustained improvements in lung function when given in addition to usual care in patients with moderate to very severe COPD1-4

- Studies investigated addition of Striverdi® Respimat® to patients' usual care background therapies in an effort to more accurately represent the real-life setting

    Lung function improvements with once daily Striverdi® Respimat® results in a higher number of COPD patients achieving clinically meaningful improvements in quality of life compared to usual care alone3
    Large global Phase III clinical trial programme in COPD - TOviTO® - to investigate the efficacy and safety of a once-daily fixed-dose combination of tiotropium plus olodaterol delivered via the Respimat® inhaler is underway

(BUSINESS WIRE) For media outside the UK, U.S. and Canada

Boehringer Ingelheim today announced the successful completion of the review process of the Marketing Authorisation Application for Striverdi® Respimat® in the European Union for patients with chronic obstructive pulmonary disease (COPD).

First approvals of Striverdi® Respimat® in United Kingdom, Denmark and Iceland are based on data from the Phase III clinical trial programme involving more than 3,500 patients with moderate to very severe COPD (GOLD spirometric level 2-4). Following the positive outcome of the review process, further national approvals in EU†/EEA‡ countries will follow in due course.

Long-lasting anticholinergic bronchodilators such as Spiriva® (tiotropium) are established as base-line maintenance therapy in the treatment of COPD.

The new Striverdi® Respimat® is both a fast-acting and long-lasting bronchodilator for the maintenance treatment of patients with COPD.

The highly selective inhaled long-acting ß2-agonist (LABA), olodaterol delivers significant bronchodilator effects within 5 minutes after the first dose2 and provides sustained improvement in FEV1 over 24 hours.4

What does this mean for patients?

The Striverdi® phase III programme showed that, compared to usual care alone, lung function improvements with once-daily Striverdi® Respimat® translated into significant improvements in patients’ quality of life, as measured by the reduction in their St George’s Respiratory Questionnaire (SGRQ)§ total score.3

“The improvements in lung function and quality of life seen with once-daily Striverdi® Respimat® are remarkable when you consider that patients in the control group were continuing with their usual care background therapies, including long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthines. We are very pleased with these results and are committed to bringing Striverdi® Respimat® to patients worldwide who need an additional treatment option,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine, Boehringer Ingelheim.

“Boehringer Ingelheim has designed Striverdi® Respimat® as a possible future combination partner for Spiriva® to provide additional bronchodilation in the maintenance treatment of COPD,” Professor Dugi continued.

“Results from our Phase III ANHELTO® studies further evaluating the efficacy and safety of a free combination of tiotropium plus olodaterol are due to be reported in early 2014. These trials are expected to show that many COPD patients will experience clinically meaningful improvements in their quality of life by combining olodaterol with tiotropium.”

“In addition, we are currently undertaking a large global Phase III clinical trial programme in COPD - TOviTO® - to investigate the efficacy and safety of a once-daily fixed-dose combination of tiotropium and olodaterol using the Respimat® inhaler.”

“Striverdi® Respimat® has the potential to be an effective new treatment option for COPD patients and represents the next step in a series of important advances from our robust pipeline of respiratory treatments. The ANHELTO® and TOviTO® trials together will give us a robust data package to support the combination of tiotropium and olodaterol,” concluded Professor Dugi.

* Olodaterol (Striverdi®) Respimat® is approved for use in COPD in Canada and Russia. Approval and regulatory reviews by health authorities in the US and other countries worldwide are pending.

† European Union

‡ European Economic Area

§ A 50-item questionnaire developed to measure health status (quality of life) in patients with COPD covering breathlessness in daily life and ability to exercise, as well as anxiety and depression. A decrease of 4 units in the SGRQ total score has been identified as the minimum clinically significant change

Please click on the link below for ‘Notes to Editors’ and ‘References’:



Boehringer Ingelheim

Linda Calandra

Corporate Communications

Media + PR

Phone: +49 151 1502 1148

Fax: +49 6132 – 77 6601

Email: press@boehringer-ingelheim.com


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