The US Food and Drug Administration has approved budesonide/glycopyrrolate/formoterol fumarate as a fixed-dose triple-combination inhaled therapy for the maintenance treatment of asthma in patients aged 12 years and older. The single-inhaler therapy combines an inhaled corticosteroid/long-acting beta2-agonist and a long-acting muscarinic antagonist.
The approval was supported by data from the Phase 3 KALOS and LOGOS trials, which included approximately 4,300 randomized patients with asthma, including those with and without recent exacerbations. Across these replicate, double-blind studies, the triple-combination therapy improved lung function compared with inhaled corticosteroid/long-acting beta2-agonist therapy. Improvements were observed in forced expiratory volume in 1 second over the first 3 hours at 24 weeks, as well as in trough lung function over 12 to 24 weeks and at 24 weeks. The therapy also demonstrated a rapid onset with improvements in lung function within 5 minutes of the initial dose. No new safety or tolerability findings were identified.
Asthma affects an estimated 27 million patients in the US, with approximately half remaining uncontrolled despite dual therapies. Ongoing airway inflammation and bronchoconstriction contribute to symptoms including wheezing, dyspnea, chest tightness, and exacerbations, with nearly 10 million asthma attacks reported annually.
“Despite the availability of dual maintenance therapy, many patients are still at risk for exacerbations and experience daily breathing difficulties, reduced lung function and the ongoing fear of worsening symptoms,” said clinical professor Njira Lugogo, MD, of the Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan. The therapy is indicated for maintenance use and is not intended for the relief of acute bronchospasm or as a substitute for rescue inhalers.
This approval represents a second indication for the therapy beyond chronic obstructive pulmonary disease, for which it was approved in the US in 2020.
Source: AstraZeneca
