Boehringer Ingelheim has announced that it has applied for approval to market its tiotropium/olodaterol Respimat soft mist inhaler for the treatment of COPD in the EU. Both of the individual drugs in the new combination inhaler are already available as Respimat products; tiotropium delivered by the SMI is marketed as Spiriva Respimat and olodaterol as Striverdi Respimat.
The company reported positive results from a Phase 3 study of the tiotropium/olodaterol Respimat in May 2014. Results showed that patients achieved better improvement in lung function with the fixed dose combination than with placebo or monotherapy with either drug.
BI Chief Medical Officer Klaus Dugi commented, “The fixed-dose combination of tiotropium and 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.”
In the announcement, BI noted, “Further submissions in additional countries will be announced in due course.”
Read the Boehringer Ingelheim press release.
