U.S. FDA approves TRIMBOW® - Chiesi’s Single Inhaler Triple Therapy - for the maintenance treatment of asthma in adults
Chiesi announces that the U.S. Food and Drug Administration (FDA) has approved its single-inhaler triple therapy (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; BDP/FF/G) for the maintenance treatment of asthma in adults.
The approval was supported by two Phase 3 clinical trials (TRIMARAN and TRIGGER) that evaluated safety and efficacy in more than 2,500 adults with uncontrolled asthma. Across the studies, BDP/FF/G demonstrated improvements in lung function compared with BDP/FF.
The safety profile was comparable with BDP/FF, with commonly reported adverse events including asthma exacerbation, nasopharyngitis and headache (among others).
Outside the United States, Chiesi’s single-inhaler triple therapy is commercialized in nearly 50 countries, including the European Union, the United Kingdom and China.
