A nonfatal myocardial infraction occurred in one patient in the treatment group.
Laboratory parameters and vital sign findings were comparable in the two groups.
Based on the findings of the GEM studies, Novartis has submitted a New Drug Application to the Food and Drug Administration; glycopyrronium is already approved in more than 70 countries, including countries in Latin America and the European Union, as a once-daily treatment marketed as the Seebri Breezhaler.
The GEM2 study was sponsored by Novartis Pharmaceuticals. Two of the study researchers are Novartis employees.