Boehringer submits tiotropium + olodaterol Respimat for European approval in COPD
German family-owned pharma major Boehringer Ingelheim says it has submitted Marketing Authorization Applications (MAAs) in 31 European countries for the once-daily fixed-dose combination of tiotropium + olodaterol Respimat 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 program. Further regulatory filings 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 LABA, delivered by the Respimat Soft Mist Inhaler.
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