After winning a first-in-class nod for its two-drug inhaler Airsupra last January, AstraZeneca is adding to the thesis that the drug can cut the risk of asthma exacerbations regardless of disease severity.
In the phase 3b BATURA trial, Airsupra—a pressurized metered-dose inhaler containing albuterol and budesonide—significantly reduced the risk of severe exacerbation when used as an as-needed rescue medication versus albuterol alone, AZ said in a release Monday.
Notably, the study looked at Airsupra’s performance in patients with intermittent or mild persistent asthma, including those on a short-acting beta2-agonist, low-dose inhaled corticosteroid maintenance therapy or leukotriene receptor antagonist maintenance therapy.
The drug-device combo’s original FDA approval in early 2023 was based on data from two other studies—MANDALA and DENALI—which trialed the drug in patients with moderate to severe or mild to moderate asthma, respectively.
“The impressive BATURA trial results add to the body of evidence supporting Airsupra as a first-in-class rescue treatment and its role in reducing the risk of asthma exacerbations in patients regardless of their disease severity, and reducing the need for systemic corticosteroids,” Sharon Barr, Ph.D., executive vice president of biopharmaceuticals R&D at AstraZeneca, said in a statement.
The latest data from BATURA were so strong that the independent data monitoring committee overseeing the trial recommended it stop early thanks to “overwhelming efficacy” at the time of AZ’s preplanned analysis, the company said in its release.
With positive results now in hand, AZ says it aims to share the BATURA readout with health authorities. The British drugmaker also plans to present the data at the annual meeting of the American College of Allergy, Asthma and Immunology on Oct. 26.
Airsupra is being developed by AstraZeneca and its partner Avillion Life Sciences.
The inhaler cleared the FDA’s desk in January 2023 as the first and only rescue medication for as-needed use to curb the risk of asthma exacerbations in adults.
Unlike traditional albuterol inhalers, which only help alleviate the symptoms of an asthma attack, Airsupra’s budesonide component helps simultaneously treat the inflammation underpinning the disease.
At the time of the FDA’s green light last year, analysts at Jefferies predicted Airsupra could generate $500 million in peak sales.
The timing of the approval was noteworthy for AstraZeneca, as well, given that the company’s former respiratory stalwart Symbicort is now facing its first generic challenger.
Last August, Viatris and Kindeva Drug Delivery launched the first Symbicort copycat in the U.S. under the brand name Breyna. Breyna is indicated for patients ages 6 and up with asthma or chronic obstructive pulmonary disease.