FDA Accepts NDA for Chiesi’s Single Inhaler Triple Therapy for Asthma

The United States (US) Food and Drug Administration (FDA) has accepted Chiesi’s New Drug Application (NDA) for its investigational single inhaler triple therapy (SITT) maintenance treatment for asthma.1

“The FDA’s acceptance of Chiesi’s NDA for our fixed-dose triple combination inhaler represents another important step in our journey to delivering solutions that address respiratory needs and reduce the burden that persists for people living with asthma, their caregivers, and the healthcare system in the US,” Martin Marciniak, Vice President of U.S. Medical Affairs at Chiesi, said in a statement.1 “Respiratory care is in our DNA--we have created medicines in this area for more than 4 decades, and transformed respiratory care by creating and commercializing the first triple therapy for asthma outside the U.S. We are bringing our respiratory expertise to the U.S. to help even more people live healthier lives.”

The SITT delivers 3 active ingredients, beclomethasone dipropionate (BDP), an inhaled corticosteroid; formoterol fumarate (FF), a long-acting beta-agonist (LABA); and glycopyrrolate (G), an anticholinergic, in a fixed dose triple combination administered twice daily in a pressurized metered-dose inhaler (pMDI).

The inhaler therapy’s efficacy and safety was validated in over 2000 participants with uncontrolled asthma in the double-blind, parallel group, randomized, active-controlled Phase 3 TRIMARAN and TRIGGER studies. Investigators in the studies found that at week 26, predose forced expiratory volume (FEV₁) improved with BDP/FF/G versus BDP/FF by 57 mL (95% CI 15–99; P = .0080) in TRIMARAN and 73 mL (26–120; P = .0025) in TRIGGER. Rates of moderate or severe exacerbations were reduced by 15% (rate ratio 0.85; 95% CI 0.73–0.99; P =.033) in TRIMARAN and 12% (0.88; 0.75–1.03; P =.11) in TRIGGER. Four patients experienced treatment-related serious adverse events—1 in TRIMARAN (BDP/FF/G group) and 3 in TRIGGER (1 in BDP/FF/G, 2 in BDP/FF). Five deaths occurred across both trials, none considered treatment-related.2

“Among the 28 million people in the U.S. who have asthma, many experience symptoms that disrupt daily life and have lasting effects on their lung health and function--and tragically, nine people die from asthma complications every day,” said Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America. “New treatment options offer the potential for improved asthma management. Expanding choices means more opportunities for patients and their care teams to find solutions that meet individual needs and improve quality of life.”

Chiesi’s SITT was previously approved for treating asthma in the European Union in February 2021. It is also approved in nearly 50 countries including the United Kingdom and China under the name Trimbow.3

References

1. Chiesi Announces FDA Acceptance of New Drug Application for its Triple Combination Inhaler for the Maintenance Treatment of Asthma. News release. Chiesi. October 15, 2025. https://finance.yahoo.com/news/chiesi-announces-fda-acceptance-drug-120500679.html

2. Virchow JC, Kuna P, Paggiaro P, et al. Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. Lancet. 2019;394(10210):1737-1749. doi:10.1016/S0140-6736(19)32215-9

3. Chiesi Group receives the European marketing authorisation for Trimbow® (beclometasone dipropionate, formoterol fumarate, glycopyrronium) an extrafine formulation fixed triple combination therapy for the treatment of asthma. News release. Chiesi. January 2, 2021. https://www.chiesi.com/en/approve-authorization-trade-combination-extrafine-triple-therapy-treatment-asthma-controlled-ics-laba/