Boehringer Ingelheim has announced the submission of Marketing Authorisation Applications (MAAs) in 31 European countries for the once-daily fixed-dose combination (FDC) of tiotropium + olodaterol Respimat®.
Boehringer Ingelheim has announced the submission of Marketing Authorisation Applications (MAAs) in 31 European countries for the once-daily fixed-dose combination (FDC) of tiotropium + olodaterol Respimat®.
It is used as a maintenance bronchodilator treatment for patients with chronic obstructive pulmonary disease (COPD).
The 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 FDC is an investigational treatment that contains the world’s most prescribed COPD maintenance therapy, tiotropium (Spiriva®), combined with olodaterol (Striverdi®), a new once-daily and fast-acting long-acting beta agonist (LABA), delivered by the Respimat Soft Mist™ Inhaler.
“The submission of tiotropium + olodaterol for marketing authorisation is a milestone for Boehringer Ingelheim and builds on nearly 100 years of experience in this therapy area of respiratory medicine,” said Dr Brian Wong, Head of Medical and Scientific Affairs, Boehringer Ingelheim UK. “Once approved, tiotropium + olodaterol will realise our commitment to constant innovation by offering patients an additional treatment option for a disease that affects over a million people in the UK.”
Building on heritage
Spiriva (tiotropium) was launched more than 11 years ago and has been shown to be an effective, well-tolerated drug for patients with the symptoms of COPD compared with placebo.
Olodaterol was specifically designed by Boehringer Ingelheim as a combination partner to tiotropium to provide added benefit 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 TOviTO clinical trial programme
The efficacy and safety of the tiotropium + olodaterol FDC are being 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 VIVACITOTM 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.
Further data from the TOviTO programme are expected to be reported later in 2014.
