In October, AstraZeneca revealed that early results from a phase 3 trial of its dual-drug asthma inhaler Airsupra were so convincing that an independent committee decided to halt the study based on evidence of “overwhelming efficacy.”
On Monday, AZ filled in the blanks, presenting data from the BATURA study, which showed that as-needed use of Airsupra reduced patients' risk of severe exacerbations by 47% compared to as-needed use of albuterol, the bronchodilator commonly used for immediate relief from asthma attacks for five decades.
In the trial, which demonstrated statistically significant and clinically meaningful improvements in all primary and secondary endpoints, patients were treated for up to 12 months. Participants were already using albuterol or other short-acting beta agonists (SABA) for immediate relief, plus low-dose inhaled corticosteroids (ICS) or leukotriene receptor antagonists (LTRA) for maintenance.
The advantage of first-in-class Airsupra is that it combines albuterol with budesonide, an anti-inflammatory corticosteroid which is used as a prophylactic for asthma patients.
“What this tells you is that, even on maintenance therapy, it’s not enough,” Pablo Panella, who is the global chief of AZ’s respiratory and immunology unit, said of the results in an interview with Fierce. “What Airsupra does is build on top of your maintenance therapy, giving extra protection that you need when you have a peak of inflammation that cannot be covered by the maintenance regimen in the moment.”
Panella and AZ presented the data at the American Thoracic Society Conference in San Francisco. The results were also published Monday in the New England Journal of Medicine.
In BATURA, while there were 160 severe exacerbations among the 1,212 patients on albuterol, there were 83 among the 1,209 patients on Airsupra. A severe exacerbation was defined as a patient needing three or more days of systemic corticosteroid (SCS) medicine, a visit to an emergency or urgent care facility, or hospitalization or death.
Additionally, adults and children age 12 and older who used Airsupra had 63% less exposure to SCS over the course of the study compared to those who used albuterol alone. Increased exposure to SCS carries additional risks, including weight gain, diabetes, hypertension and cardiovascular issues.
The BATURA study was the third successful phase 3 trial of Airsupra and offers evidence of the value of the inhaler in a different subset of patients—those with intermittent to mild asthma. It’s a group that includes more than half of those with the disorder and who account for up to 30% of asthma-related exacerbations.
In the MANDALA study, which was made up of patients with moderate to severe asthma, Airsupra reduced the risk of exacerbations by 27% and mean annualized SCS exposure by 33% compared to albuterol.
“These are patients that are already treated with much more aggressive therapy,” Panella said of those in the MANDALA study. “What this is telling you is, even though we consider mild asthma mild, it is not. We are seeing that probably many of these patients are severely undertreated and probably at higher risk than patients which are already defined as moderate to severe.”
MANDALA was one of two trials that backed the FDA approval of Airsupra in January 2023 as it became the only rescue medication to reduce the risk of asthma exacerbations.
“The additional benefit that the Batura data brings is that now we have comprehensive data that, irrespective of the severity of your disease, adding Airsupra to whatever regimen you have is better for your patient,” Panella said. “This simplifies the clinical proposition quite substantially.”
Airsupra was developed initially by London-based biotech Avillion Life Sciences, which partnered (PDF) with AZ subsidiary Pearl Therapeutics in a 2018 deal.
Airsupra was launched 12 months after its approval and has generated increased sales in each of the four full quarters it has been on the market, including $28 million in the first three months of this year. Upon its approval, analysts from Jefferies pegged its peak sales potential at $500 million.
Airsupra is one of several assets in AZ’s thriving respiratory and immunology portfolio, which accounted for $7.9 billion in sales in 2024 for a year-over-year increase of 23%. The company sees a major opportunity for growth, estimating the market for R&I products increasing from $130 billion to $200 billion over the next 10 years.
AZ's top R&I drugs last year were asthma and chronic obstructive pulmonary disorder (COPD) inhaler Symbicort and biologic asthma treatment Fasenra, which racked up sales of $2.9 billion and $1.7 billion, respectively. Newer drugs on their way to becoming blockbusters this year are three-in-one inhaler Breztri, which is a maintenance therapy for COPD, and Amgen-partnered biologic treatment Tezspire, which is on the market for asthma. These drugs achieved sales of $978 million and $684 million, respectively, in 2024.
Meanwhile, AZ is working to expand Fasenra, Tezspire and IL-33 candidate tozorakimab into COPD. The company believes there is value in bringing multiple biologics to the indication.
“Sometimes we think of COPD as a single disease. It actually isn’t,” Panella said. “There are many differential biological drivers in this disease and we think that probably you need different biologics to tackle different sub-patient populations to really drive down the unmet need that we see in COPD and drive down mortality in COPD.”