FDA Approves Updated AIRSUPRA Label Showing 46% Reduction in Asthma Attacks for Mild Asthma Patients
核心洞察
The FDA has approved an updated label for AIRSUPRA (albuterol/budesonide) that includes evidence from the BATURA Phase IIIb trial demonstrating a 46% reduction in severe asthma exacerbations compared to albuterol alone in mild asthma patients.
The BATURA trial enrolled 2,421 participants and showed AIRSUPRA significantly reduced the risk of severe exacerbations with a hazard ratio of 0.54 (95% CI: 0.40, 0.72; p<0.001) over 12-52 weeks of treatment.
AIRSUPRA represents the first and only anti-inflammatory rescue medication approved in the US, combining albuterol with budesonide to address both symptoms and underlying inflammation in asthma patients aged 18 and older.
The US Food and Drug Administration has approved a supplemental new drug application for AIRSUPRA (albuterol/budesonide), updating the prescribing information to include clinically meaningful evidence from the BATURA Phase IIIb trial in patients with mild asthma. The updated label demonstrates that AIRSUPRA significantly reduced the risk of severe asthma exacerbations by 46% compared to albuterol alone in adult patients with mild asthma.
BATURA Trial Results Demonstrate Superior Efficacy
The BATURA Phase IIIb trial, a randomized, double-blind, parallel-group study, compared the efficacy and safety of as-needed AIRSUPRA (albuterol 180 mcg/budesonide 160 mcg) versus as-needed albuterol (180 mcg) in 2,421 participants over 12-52 weeks. The trial demonstrated that AIRSUPRA treatment significantly reduced the risk of severe exacerbations with a hazard ratio of 0.54 (95% confidence interval: 0.40, 0.72; p<0.001).
Participants were aged 12 years and older with intermittent or mild persistent asthma who had been using as-needed short-acting beta agonist (SABA) only, or as-needed SABA with either low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance therapy. The study was randomized 1:1 with 1,209 patients receiving AIRSUPRA and 1,212 receiving albuterol as needed.
The primary efficacy endpoint was time to first severe asthma exacerbation during the study period. Secondary endpoints included annualized severe exacerbation rate and annualized total systemic corticosteroid dose. A severe exacerbation was defined as worsening symptoms resulting in three or more days of systemic corticosteroid use, an emergency department visit, urgent care visit, hospitalization for asthma, or death.
First-in-Class Anti-Inflammatory Rescue Treatment
AIRSUPRA is the first and only anti-inflammatory rescue medication approved in the US for as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. The medication combines albuterol, a SABA, with budesonide, a corticosteroid, in a pressurized metered-dose inhaler using AstraZeneca's Aerosphere delivery technology.
The inclusion of BATURA study results builds upon previous Phase III trials, including the MANDALA trial in adult patients with moderate to severe asthma and the DENALI lung function trial in patients with mild to moderate asthma. Together, these trials demonstrate the benefit of as-needed AIRSUPRA in reducing the risk of severe exacerbations across all asthma severities compared to albuterol.
Clinical Expert Perspectives
Dr. Reynold A. Panettieri Jr, Vice Chancellor and Professor of Medicine at Rutgers Institute for Translational Medicine and Science, commented: "This label update approved by the FDA ensures that the critical evidence for AIRSUPRA in mild asthma is now included in the prescribing information, allowing physicians to make the most informed decisions about rescue medicine for their patients. This update, along with the recent GINA Report, supports an anti-inflammatory rescue approach for adults of all asthma severities."
Liz Bodin, Vice President, US Respiratory & Immunology at AstraZeneca, stated: "Patients living with asthma deserve a treatment that offers more than just relief from their symptoms. With this label update for AIRSUPRA, which includes proven benefits for mild asthma, patients across all asthma severities have a superior choice for their asthma rescue medication."
Addressing Unmet Medical Need
Asthma affects approximately 27 million people in the US and 262 million worldwide. The disease is characterized by chronic inflammation, and patients are at risk of severe exacerbations regardless of disease severity, treatment adherence, or level of control. There are an estimated 136 million asthma exacerbations globally per year, including more than 11 million in the US.
Traditional SABA-only rescue treatments like albuterol do not address the underlying inflammation central to both asthma symptoms and exacerbations, leaving patients at risk of severe exacerbations that can result in impaired quality of life, hospitalization, and frequent oral corticosteroid use. The Global Initiative for Asthma has recommended against SABA-only treatment of asthma in adults since 2019, and the 2025 GINA Report supports an anti-inflammatory rescue approach in adults of all asthma severities.
Safety Profile and Administration
Safety findings in the BATURA trial demonstrated that AIRSUPRA was consistent with its established safety profile. The medication is administered as 2 inhalations as needed, with a maximum of 12 puffs (6 doses) within a 24-hour period. AIRSUPRA is not intended as maintenance treatment for asthma, and patients should continue their prescribed long-term asthma control medications as directed.
The BATURA trial utilized a first-ever decentralized, patient-centric design that allowed participants to accommodate trial-related activities around their daily lives, intended to remove logistical barriers and increase equitable access to the study. The positive results were published in the New England Journal of Medicine and presented at the American Thoracic Society 2025 International Conference in San Francisco.
AIRSUPRA was developed through a collaboration between AstraZeneca and Avillion (搜索), with AstraZeneca commercializing the medicine following its successful approval.