U.S. FDA Approves Chiesi’s TRIMBOW® Single Inhaler Triple Therapy for the Maintenance Treatment of Asthma

• TRIMBOW^® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G) is the first U.S. FDA-approved product from Chiesi's respiratory portfolio, bringing with it more than four decades of global expertise in respiratory leadership.
• Approval was supported by Phase 3 TRIMARAN and TRIGGER studies, which included lung function as a co-primary endpoint in adults with asthma,¹ building on its long-standing use as the first therapy in its class approved outside the U.S.

Cary, N.C., May 18, 2026-Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved TRIMBOW® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G; 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg) for the maintenance treatment of asthma in adults. TRIMBOW delivers three active ingredients in a single device, referred to as a single inhaler triple therapy (SITT), presenting an option for adults whose asthma may require more than one inhaled medicine for daily maintenance treatment. TRIMBOW was the first treatment approved in the single inhaler triple therapy class outside of the U.S. and is commercialized in nearly 50 countries, including those within the European Union, the United Kingdom, and China.

Approximately 27 million people in the U.S. live with asthma, which remains a significant burden to patients, caregivers, and society.² Roughly 50% to 91% of people across all asthma disease severities show evidence of Small Airway Disease (SAD), which affects the tiny bronchioles deep within the airway tree.^3,4

"The approval of TRIMBOW marks an important milestone as healthcare professionals continue to expand options for individualized care for the millions of people in the U.S. living with asthma, many of whom still struggle with symptoms,"² said Nicola Hanania, MD, MS, Director, Airways Clinical Research Center, Professor of Medicine, Baylor College of Medicine and Chief, Section of Pulmonary, Critical Care and Sleep Medicine, Ben Taub Hospital, Houston, Texas. "This treatment has demonstrated improvement in lung function in Phase 3 clinical trials."¹

The FDA approval is supported by data from two Phase 3, double-blind, parallel-group, randomized, active-controlled clinical trials, TRIMARAN and TRIGGER, that evaluated the safety and efficacy of TRIMBOW in more than 2,200 adults with uncontrolled asthma.¹ Across studies, TRIMBOW demonstrated improvements in lung function compared with BDP/FF, an inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) product. TRIMBOW demonstrated a safety profile comparable with BDP/FF, with common adverse events, occuring at an incident rate greater than or equal to 1%, including bronchitis, hypertension, back pain, blood pressure increase, dysphonia, upper respiratory tract infection, influenza, anemia, muscle spasms, laryngitis, oropharyngeal pain, and sinusitis.¹

"This is an important development for the community at a time when access to treatment and the cost of care remain significant challenges for many individuals living with asthma," said Lynda Mitchell, MA, CAE, CEO of the Allergy & Asthma Network. "There is no cure for asthma, and the condition presents a major burden to patients, caregivers, and society. Patients benefit when they have more options to treat their asthma - we are eager to see continued progress in innovation to address ongoing unmet needs in asthma care."

About Asthma

Asthma is a chronic, inflammatory respiratory disease that causes inflammation in the airways. People who have asthma can experience symptoms such as shortness of breath, wheezing, coughing, and chest tightness - often every day for those with severe cases.⁵

For many adults, symptoms remain difficult to manage - roughly 30% to 50% of patients experience frequent symptoms, which can lead to trips to the emergency room, missed work, and interruption to daily activities.^6,7

Severe asthma attacks can be life-threatening.⁸ Centers for Disease Control and Prevention (CDC) data show that more than 3,300 adults die from asthma each year in the U.S., which is an average of nine deaths per day.⁹ Asthma also places a major burden on the healthcare system and economy, costing the U.S. an estimated $82 billion annually.¹⁰

About TRIMBOW (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; BDP/FF/G)

TRIMBOW (BDP/FF/G) is an FDA-approved triple combination inhaler for the maintenance treatment of asthma in adults. It contains three active ingredients: beclomethasone dipropionate (BDP), an inhaled corticosteroid (ICS); formoterol fumarate (FF), a long-acting beta-agonist (LABA); and glycopyrrolate (G), an anticholinergic. TRIMBOW is administered as a twice-daily, fixed-dose therapy via a pressurized metered-dose inhaler (pMDI) and is available in two strengths: 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg.¹

Chiesi's robust clinical trial program evaluated the safety and efficacy of BDP/FF/G in more than 2,200 patients with uncontrolled asthma.¹ TRIMBOW was the first fixed triple combination in a single inhaler approved outside the U.S. and is now commercialized in nearly 50 countries, including the European Union, the United Kingdom, and China.¹¹

About Chiesi USA

Chiesi USA, Inc., headquartered in Cary, North Carolina, is more than a global biopharmaceutical company - it is a team of people driven by a deep passion to make life better for others, and to do so in a responsible way. For over 90 years, we've been dedicated to developing innovative treatments, currently focused on respiratory health, rare diseases and specialty care. Chiesi USA is a wholly owned subsidiary of privately-owned Chiesi Farmaceutici S.p.A, a global R&D-focused pharmaceutical company based in Parma, Italy. In the United States, the company delivers therapies and enhances care for patients in the areas of acute cardiology, neonatology, cystic fibrosis, rare diseases, and now respiratory. We're proud to have been certified as a B Corporation™ since 2019, using business as a force for good - for today's patients, tomorrow's generations, and the world we all share.12 For more information, visit https://www.chiesiusa.com.

Indication and Important Safety Information

Approved Use

TRIMBOW^® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) is a prescription medicine used long term to treat asthma in adults. TRIMBOW is available in 2 strengths: 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg, each taken as 2 inhalations twice daily. TRIMBOW is not used to relieve sudden breathing problems and won't replace a rescue inhaler.

Limitations of Use

TRIMBOW is not used to relieve sudden breathing problems and will not replace a rescue inhaler.

Important Safety Information

TRIMBOW contains formoterol fumarate (FF). Long-acting beta₂-adrenergic agonist (LABA) medicines such as FF, when used alone, increase the risk of hospitalizations and death from asthma problems. TRIMBOW contains an inhaled corticosteroid (ICS), an anticholinergic, and a LABA. When an ICS and LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.

Do not use TRIMBOW to relieve sudden breathing problems. Always have a rescue inhaler with you to treat sudden symptoms.

TRIMBOW should not be used in children. It is not known if TRIMBOW is safe and effective in children.

Do not use TRIMBOW if you are allergic to any of the ingredients. Ask your healthcare provider if you are not sure.

Do not use TRIMBOW more often than prescribed. TRIMBOW should be taken as 2 puffs, 2 times each day. Do not take more than 4 inhalations per day.

Do not take TRIMBOW with other medicines that contain a LABA or an anticholinergic for any reason. Tell your healthcare provider about all your medical conditions and about all the medicines you take.

Call your healthcare provider or get medical care right away if your breathing problems get worse, if you need your rescue inhaler more often than usual or it does not work as well to relieve your symptoms.

TRIMBOW can cause serious side effects, including:

• fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using TRIMBOW to help reduce your chance of getting thrush.
• weakened immune system and increased chance of getting infections (immunosuppression).
• reduced adrenal function (adrenal insufficiency). This can happen when you stop taking oral corticosteroids and start taking inhaled corticosteroids.
• sudden breathing problems immediately after inhaling TRIMBOW. If this happens, stop using TRIMBOW and call your healthcare provider right away.
• serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction: rash, hives, swelling of your face, mouth and tongue, or breathing problems.
• effects on heart: increased blood pressure; a fast or irregular heartbeat, awareness of heartbeat; chest pain.
• effects on nervous system, including tremor or nervousness.
• bone thinning or weakness (osteoporosis).
• eye problems including glaucoma, increased pressure in your eye, cataracts, blurred vision, worsening of narrow-angle glaucoma, or other changes in vision. You should have regular eye exams while using TRIMBOW. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include: eye pain or discomfort; nausea or vomiting; blurred vision; seeing halos or bright colors around lights; red eyes. If you have these symptoms, call your healthcare provider right away before taking another dose.
• new or worse urinary retention. Symptoms may include: difficult, painful, or frequent urination; urination in a weak stream or drips. If you have these symptoms, stop taking TRIMBOW and call your healthcare provider right away before taking another dose.
• changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).
• slowed growth in children.

Common side effects of TRIMBOW include: bronchitis; high blood pressure; back pain; hoarseness or laryngitis; upper respiratory tract infection (such as itchy, runny or blocked nose, inflammation of the nasal lining, sore throat); flu; low red blood cells (anemia); muscle spasms; mouth and throat pain; inflammation of the sinuses.

These are not all the possible side effects of TRIMBOW.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Chiesi USA, Inc. at 1-888-661-9260.

Please see Full Prescribing Information, including Patient Information, for TRIMBOW.

References

1. TRIMBOW^® U.S. Prescribing Information
2. Centers for Disease Control and Prevention. (2024, November 21). Most Recent Asthma Data. U.S. Department of Health & Human Services. https://www.cdc.gov/asthma-data/about/most-recent-asthma-data.html
3. Postma DS, Brightling C, Baldi S, Van den Berge M, Fabbri LM, Gagnatelli A, Papi A, Van der Molen T, Rabe KF, Siddiqui S, Singh D, Nicolini G, Kraft M; ATLANTIS study group. Exploring the relevance and extent of small airways dysfunction in asthma (ATLANTIS): baseline data from a prospective cohort study. Lancet Respir Med. 2019 May;7(5):402-416. doi: 10.1016/S2213-2600(19)30049-9. https://pubmed.ncbi.nlm.nih.gov/30876830/.
4. Omar S. Usmani, Dave Singh. et al. (2016). The prevalence of small airways disease in adult asthma: A systematic literature review. Respiratory Medicine. 2016, Vol. 116, pp. 19-27. https://doi.org/10.1016/j.rmed.2016.05.006.
5. Centers for Disease Control and Prevention. (2023, September 27). Asthma: About. U.S. Department of Health & Human Services. https://www.cdc.gov/asthma/about/index.html
6. Zhang, S., White, J., Hunter, A.G. et al. npj Prim. Care Respir. Med. 33, 19 (2023). Suboptimally controlled asthma in patients treated with inhaled ICS/LABA: prevalence, risk factors, and outcomes. https://doi.org/10.1038/s41533-023-00336-9
7. American Lung Association (ALA). (2020). Uncontrolled Asthma vs. Severe Asthma: How to Get the Right Diagnosis. Retrieved from https://www.lung.org/blog/uncontrolled-asthma-vs-severe
8. Centers for Disease Control and Prevention. (2024, February 13). Asthma. National Center for Health Statistics. https://www.cdc.gov/nchs/fastats/asthma.htm
9. Centers for Disease Control and Prevention. (2024, November 21). Most Recent Asthma Data. U.S. Department of Health & Human Services. https://www.cdc.gov/asthma-data/about/most-recent-asthma-data.html
10. Nurmagambetov, T., Kuwahara, R., & Garbe, P. (2018). The economic burden of asthma in the United States, 2008-2013. Annals of the American Thoracic Society, 15(3), 348-356. https://www.atsjournals.org/doi/10.1513/AnnalsATS.201703-259OC
11. Chiesi Group. (2021, February 1). Chiesi Group receives the European marketing authorisation for Trimbow^® (beclometasone dipropionate, formoterol fumarate, glycopyrronium)... Chiesi Group. https://www.chiesi.com/en/approve-authorization-trade-combination-extrafine-triple-therapy-treatment-asthma-controlled-ics-laba/
12. Chiesi Air U.K. (n.d.) Introducing Chiesi Air Medicines. https://www.chiesiair.co.uk/hcp/products/

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