Boehringer Ingelheim submits applications in Europe for tiotropium + olodaterol Respimat® fixed-dose combination in COPD

Boehringer Ingelheim today announced submission of Marketing Authorisation Applications in 31 European countries for the once-daily fixed-dose combination of tiotropium + olodaterol in the Respimat® Soft Mist™ Inhaler as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD). These applications are based on data from the large Phase III TOviTO™ clinical trial programme.  Further submissions in additional countries will be announced in due course.

Tiotropium + olodaterol fixed-dose combination is an investigational treatment that contains the leading COPD maintenance therapy worldwide, tiotropium (Spiriva®), combined with olodaterol (Striverdi®), the new once-daily and fast-acting LABA^‡, delivered by the Respimat® Soft Mist™ Inhaler.

“With more than 90 years’ experience in the field of respiratory diseases and our leadership in the treatment of COPD, Boehringer Ingelheim is committed to continuing to bring innovative treatment options to physicians and patients,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “The fixed-dose combination of tiotropium + olodaterol represents another major advance from our robust respiratory portfolio. Once approved, we believe it will make an important contribution to addressing the current unmet needs of the millions of patients whose ability to lead a full life is disrupted by COPD.”

Spiriva® (tiotropium) has been proven to consistently reduce the risk of COPD exacerbations, provide long-term improvement in quality of life for patients and has a favourable impact on survival^#. Olodaterol was specifically designed by Boehringer Ingelheim as a combination partner to Spiriva® to provide added benefits for patients with COPD.

Olodaterol monotherapy has received approval for the maintenance treatment of COPD in over 30 countries and is marketed under the brand name Striverdi® Respimat® in countries where it is available. The Respimat® Soft Mist™ Inhaler is an innovative inhaler delivering a unique slow-moving Soft Mist™ that allows gentle inhalation – making it easy for patients to take their therapy.

The efficacy and safety of the tiotropium + olodaterol FDC are evaluated in the Phase III TOviTO™ clinical trial programme. Involving more than 8,000 patients, TOviTO™ is one of the largest trial programmes ever conducted in COPD.  In addition to evaluating the effects of the tiotropium + olodaterol FDC on lung function, TOviTO™ is also focused on the evaluation of other important clinical outcomes related to the daily life of patients with COPD including quality of life, breathlessness and ability to exercise.

In the 6-week VIVACITO™ study, the first study reported from the TOviTO™ programme, the tiotropium + olodaterol FDC demonstrated clear and consistent improvements in lung function (FEV₁^*) over 24 hours compared with tiotropium or olodaterol monotherapies, and placebo. It was shown to have a safety profile similar to its single components.

Data from the pivotal 52-week Phase III TONADO™ 1&2 trials formed the major part of the regulatory submission. The trials investigated the effect of the tiotropium + olodaterol FDC on lung function and quality of life in patients with moderate to severe COPD.  Results from TONADO™ 1&2 as well as other TOviTO™ programme data are expected to be reported later in 2014.

*FEV₁ is the maximum volume of air that can be forcibly expired in 1st second, following maximal inspiration and is an important indicator of lung function. FEV₁ is reduced in obstructive respiratory diseases
^†Tiotropium + olodaterol fixed-dose combination is an investigational treatment.  It has not been approved for clinical use. Its safety and efficacy have not yet been fully established
^‡Long-acting beta2-agonist
^#The favourable impact on survival was established in UPLIFT® for Spiriva® Handihaler® over 4 years.TIOSPIR™ showed a similar impact for Spiriva® Respimat® compared to Spiriva® HandiHaler®