Airsupra is a prescription combination rescue inhaler for as-needed use to reduce the risk of asthma exacerbations in adults that was recently approved this year. It is a combination of albuterol (a beta-2 adrenergic agonist) and budesonide (a corticosteroid)1. It is administered as a dose of 2 inhalations (puffs) as needed. Airsupra is the first in it’s class as a combined SABA/ICS product, with the idea being that ICS delivery administered on SABA rescue will help decrease the frequency of future exacerbations.
Clinical Trials
The U.S. approval of Airsupra was “based on positive results from a global phase III clinical trial program comprising four studies involving more than 4,000 patients (including the MANDALA and DENALI trials), which was conducted successfully by Avillion under an exclusive clinical co-development agreement with AstraZeneca”, reports Avillion.
The MANDALA trial was published in the New England Journal of Medicine in 2022 and showed that the higher-dose combination of albuterol-budesonide significantly reduced asthma exacerbations when compared to albuterol alone when used for 24 weeks.
Patient Population
Airsupra was primarily studied in adults and adolescents with moderate-to-severe asthma, some of whom were already on a scheduled maintenance inhaler regimen, which they continued throughout the trial. Some children were included in the MANDALA trial, but there were not enough participants to draw conclusions about risk compared to efficacy in this group.
Adverse Effects
In the MANDALA trial, side effects were similar between the Airsupra and albuterol groups, with the exception of nasopharyngitis, which was seen more frequency in the high-dose group (7.5% compared to 5.1% in the albuterol group).
Studies have suggested that high doses of ICS over a long period of time may lead to a slight reduction in growth velocity in children. However, the effect is generally small, and the benefits of controlling asthma typically outweigh the risk of growth suppression. Because of this risk, the FDA did not have enough data to approve this drug for use in children.
Cost
Cost information has not yet been published by AstraZeneca, but should become available later this year. As a branded product that is first in its class, it is likely that it will be expensive similar to Symbicort ($300 to $350). Further drug approvals in this class should help reduce the price for patients.
Airsupra Conclusion
The Global Initiative for Asthma (GINA) currently recommends a combined ICS-LABA for initial as-needed treatment of symptoms, specifically budesonide-formoterol (Symbicort). They also suggest that an ICS is an essential part of asthma treatment and should be included at all stages.
We have yet to see if an updated 2023 report will include information on Airsupra, but it is likely that this will become a critical part of asthma management.
Interested in other new FDA approvals? See our post on Brenzavvy (bexagliflozin)