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

• 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

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.

About olodaterol

Olodaterol is a highly selective, long-acting beta2-agonist (LABA) for the once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is approved for use in the treatment of COPD in Canada and Russia; approval and regulatory reviews by health authorities in the US and other countries worldwide are pending.

Phase III trials have shown that the addition of Striverdi® Respimat® once-daily over 48 weeks achieved statistically significant improvements in lung function vs. usual care alone (p<0.05),1-3 which were comparable to those shown with formoterol Aerolizer® 12 µg twice-daily.²

In addition, the lung function improvements with once-daily Striverdi® Respimat® resulted in more COPD patients achieving clinically meaningful improvements in quality of life compared to usual care.³

A responder analysis showed that, compared to usual care alone, a statistically significant, greater number of COPD patients treated with Striverdi® Respimat® had a decrease in their SGRQ§ total score greater than the minimal clinically important difference (MCID) of 4 units (P<0.001).³

Safety data from the four 48-week Phase III parallel pivotal studies: two comparing olodaterol Respimat® vs. usual care alone and two comparing olodaterol Respimat® vs. formoterol Aerolizer® twice-daily, showed that, overall, the frequency of adverse events (AE) experienced with olodaterol Respimat® was comparable to both placebo and the active comparator formoterol.⁵ The most common AE was COPD exacerbations.⁵

Boehringer Ingelheim is developing olodaterol as a combination partner for tiotropium to provide additional bronchodilation in the maintenance treatment of patients with COPD. Combining a long-acting anticholinergic (LAMA) and a LABA has the potential to deliver increased bronchodilatory benefits in COPD symptoms and consistency of treatment response, compared to monotherapy.⁶,⁷

About SPIRIVA® (tiotropium bromide) in COPD

SPIRIVA®, a long-acting anticholinergic medication, is the first inhaled maintenance treatment to provide significant and sustained improvements in lung function with once-daily dosing. SPIRIVA® positively impacts the clinical course of COPD, helping to change the way patients live with their disease.8 Since SPIRIVA® was first introduced over ten years ago, it has become the most prescribed maintenance treatment for COPD worldwide. SPIRIVA® helps COPD patients breathe more easily by opening narrowed airways and helping to keep them open for 24 hours. It works through targeting of a dominant reversible mechanism of COPD – cholinergic bronchoconstriction.

SPIRIVA® is delivered via HandiHaler®, a breath-actuated, single-dose dry powder inhaler, or by the SPIRIVA® Respimat® Soft MistTM Inhaler.

About Respimat® Soft MistTM Inhaler

Developed by Boehringer Ingelheim, Respimat® Soft MistTM Inhaler (SMI) is a novel inhaler delivering a unique slow-moving Soft MistTM that allows gentle inhalation – making it easy to inhale,9-11 and is preferred by patients compared to other currently available inhalers.¹²,¹³

About COPD

COPD is a chronic lung syndrome, including chronic bronchitis and emphysema, dominated by progressive air flow limitation. Major symptoms are shortness of breath, chronic cough and sputum, and repeated exacerbations.¹⁴

COPD is caused by long-term inhalation exposure to pollutants and noxious particles, most commonly cigarette smoke.¹⁴

As COPD progresses, lung function declines and physical activity may become severely limited, disrupting the patient’s ability to lead a full life, interfering with everyday tasks and participation in family routines.¹⁴ This can lead to people feeling, anxious, isolated and depressed.¹⁴,¹⁵

Bronchodilator medications are central to symptom management in COPD7 and inhaled bronchodilators are recommended in guidelines as first choice for the initial pharmacological management of COPD.¹⁴

For patients who remain symptomatic on one bronchodilator, the combination of two bronchodilators with different modes of action – a LAMA with a LABA – has the potential to be more effective in improving airflow and in helping patients with COPD to achieve better outcomes, compared to existing treatment options.⁶,⁷

References

* 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

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