Trade Resources Industry Views Boehringer Ingelheim Has Obtained Marketing Approval for Striverdi Respimat

Boehringer Ingelheim Has Obtained Marketing Approval for Striverdi Respimat

Boehringer Ingelheim has obtained marketing approval for Striverdi Respimat (olodaterol), a long-lasting bronchodilator indicated for chronic obstructive pulmonary disease (COPD), in the UK, Denmark and Iceland.

Boehringer Ingelheim Obtains EU Approval for Striverdi Respimat

This approval is based on the positive results from the Striverdi Phase III clinical trial program involving more than 3,500 patients with moderate to very severe COPD (GOLD spirometric level 2-4).

Phase III trials have shown that administration of once-daily Striverdi Respimat for 48 weeks provided fast, remarkable and sustained improvements in lung function when given in addition to usual care in patients with moderate to very severe COPD.

Striverdi Respimat has been designed by the company as a possible future combination partner for Spiriva to provide additional bronchodilation in the maintenance treatment of COPD.

Olodaterol is a highly selective inhaled long-acting beta2-agonist for the once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

Boehringer Ingelheim corporate senior vice president medicine Dr Klaus Dugi noted the improvements in lung function and quality of life seen with once-daily Striverdi Respimat are remarkable when considered 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 xanthenes.

"We are very pleased with these results and are committed to bringing Striverdi Respimat to patients worldwide who need an additional treatment option.

"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.

"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," Dr Dugi added.

Currently, Boehringer Ingelheim is undertaking a global Phase III clinical trial program in COPD - TOviTO - to evaluate the efficacy and safety of a once-daily fixed-dose combination of tiotropium and olodaterol using the Respimat inhaler.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/boehringer-ingelheim-obtains-eu-approval-for-striverdi-respimat-211013
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Boehringer Ingelheim Obtains EU Approval for Striverdi Respimat