Boehringer Ingelheim has submitted an application in Europe seeking to market its tiotropium (Spiriva)/olodaterol (Striverdi) fixed-dose combo for chronic obstructive pulmonary disorder (COPD).
The drugs, which are delivered via the Respimat Soft Mist Inhaler, are intended to serve as a maintenance bronchodilator for COPD patients.
The submission is backed by data from the Phase III TOviTO clinical trial programme, which involved more than 8,000 patients and showed that the combination induced clear and consistent improvements in lung function (FEV1) over 24 hours each component alone and placebo.
Also, it was shown to have a safety profile similar to each standalone agent, the German drugmaker said.
According to Professor Klaus Dugi, BI’s Chief Medical Officer, the fixed-dose combination of tiotropium and olodaterol represents a “major advance”.
“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,” he noted.