The MAAs are based on data from the large Phase III TOviTO clinical trial program and further regulatory filings in other countries will be announced in due course.
Tiotropium + olodaterol FDC contains the most prescribed COPD maintenance therapy in the world, tiotropium (Spiriva), combined with olodaterol (Striverdi), a new once-daily and fast-acting LABA‡, delivered by the Respimat Soft Mist Inhaler.
Boehringer Ingelheim chief medical officer Klaus Dugi said the fixed-dose combination of tiotropium + olodaterol represents another major advance from the company’s 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," Dugi said.
According to the company, Spiriva 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.
Boehringer has specifically designed olodaterol as a combination partner to Spiriva in order to provide added benefits for patients with COPD.
The efficacy and safety of the combination drug are assessed in the Phase III TOviTO clinical trial program, which included over 8,000 patients.
Image: Boehringer Ingelheim Center (BIC), the Corporate Headquarters Building in Ingelheim, Germany. Photo: courtesy of Boehringer Ingelheim GmbH.