The FDA has approved a fixed-dose triple combination therapy for the maintenance treatment of asthma in adults and children aged 12 years and older, according to a press release from manufacturer AstraZeneca. 

Marketed as Breztri, the single inhaler combines budesonide (320 μg), glycopyrrolate (36 μg) and formoterol fumarate (9.6 μg). The drug, also referred to as BGF, was approved for the treatment of chronic obstructive pulmonary disease (COPD) in 2020. 

The approval for asthma was based on data from a pair of phase 3 studies, KALOS and LOGOS, in which treatment with BGF significantly improved lung function from baseline over 24 weeks, based on forced expiratory volume in 1 second (FEV₁). The studies, which included approximately 4300 individuals, also compared the safety and efficacy of BGF to budesonide/formoterol fumarate (BFF), a current dual therapy for asthma. 

Overall, the least squares mean differences in change from baseline to 24 weeks for morning pre-dose trough FEV₁ and in FEV₁ area under the curve from 0 to 3 hours was significantly greater in BGF patients compared to BFF patients. In addition, BGF significantly reduced severe exacerbations compared to BFF. 

Adverse events were similar across the groups and similar to those seen in other studies. The most common adverse reactions associated with BGF — with an incidence of at least 2% — include upper respiratory tract infection, pneumonia, back pain, oral candidiasis, influenza, muscle spasm, urinary tract infection, cough, sinusitis, and diarrhea, as noted in the drug’s prescribing information. 

The drug is currently approved for the treatment of COPD in adults in approximately 90 countries worldwide — including the United Sates, the European Union, China, and Japan — and is under review as a treatment for asthma in areas including the European Union, China, and Japan. 

New Options Benefit Uncontrolled Patients 

Additional treatments for asthma are important, as a substantial proportion of patients with asthma remain uncontrolled despite inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) therapy, said Diego J. Maselli, MD, professor and chief of the Division of Pulmonary Diseases & Critical Care at University of Texas Health at San Antonio.

“The availability of another option for triple therapy in a single inhaler with ICS/LABA/[long acting muscarinic antagonist] is a welcome addition for step-up treatment in asthma,” said Maselli, who was not involved in the drug approval studies. Given the varying patient preferences for inhaler devices, such as metered-dose vs dry-powder inhalers, the availability of alternative formulations is important, he added. 

Some persistent barriers for triple therapies in a single inhaler in asthma are cost and limited accessibility for patients, not all of whom are able to benefit from patient assistance programs, Maselli told Medscape Medical News. However, shared decision-making remains a central component of asthma care, and involving the patients in a greater selection of therapy is now possible. 

“Fortunately, triple therapy has previously demonstrated a favorable safety profile, and the most recent clinical trials in asthma did not show any new safety concerns,” Maselli said. 

Full prescribing information is available here. 

The KALOS and LOGOS studies were supported by AstraZeneca. Maselli disclosed serving as a consultant for GSK and AstraZeneca but was not involved in the KALOS and LOGOS studies.