In continuation of my update on beclomethasone, Formoterol & Glycopyrrolate
Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, announced the U.S. Food and Drug Administration approval of 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.
- 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.
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
