Albuterol/Budesonide

AstraZeneca (AZ) has shared positive results from a phase 3b study of its anti-inflammatory reliever rescue therapy Airsupra (albuterol/budesonide) in patients with mild asthma. Data presented at this year’s American Thoracic Society International Conference showed that as-needed Airsupra led to statistically significant and clinically meaningful improvements in all primary and secondary endpoints compared to as-needed albuterol, the most commonly used rescue medicine in the US. The BATURA study enrolled patients aged 12 years and older with intermittent or mild persistent asthma who were already using as-needed albuterol or other short-acting beta agonists (SABAs) and were on a background of either low-dose inhaled corticosteroids or leukotriene receptor antagonists maintenance therapy. AZ and Avillion Life Sciences, which co-developed Airsupra, announced in October that “overwhelming efficacy” results at a pre-planned analysis of BATURA led to an independent data monitoring committee recommending that the trial be ended early. Now, full results from the study showed that Airsupra reduced the risk of severe exacerbations by 47% compared with albuterol alone. Patients receiving Airsupra also had 63% lower exposure to total systemic corticosteroids, which control inflammation but are associated with an increased risk of adverse health conditions, over the treatment period compared to those in the albuterol-only cohort. Affecting more than 25 million people in the US, asthma is a long-term inflammatory disease that can cause symptoms such as recurrent breathlessness and wheezing, and a tight chest. Patients remain at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control, with more than ten million asthma exacerbations occurring in the US every year. In January 2023, Airsupra became the first and only anti-inflammatory rescue medication to be approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. This was supported by positive results from the phase 3 MANDALA and DENALI trials, which evaluated Airsupra in patients with moderate-to-severe asthma and mild-to-moderate asthma, respectively. Sharon Barr, executive vice-president and head of biopharmaceuticals research and development at AZ, said: “The exciting results from the BATURA trial, coupled with the findings from MANDALA and DENALI, clearly demonstrate the superiority of Airsupra over albuterol alone across all asthma severities. “We hope these comprehensive results accelerate the use of anti-inflammatory rescue therapy as the preferred standard of care…”

Looking to introduce a new standard-of-care asthma rescue therapy across a broader age group, AstraZeneca unveiled detailed results from a Phase IIIb study of Airsupra (albuterol/budesonide) at the American Thoracic Society (ATS) annual meeting on Monday.The UK pharma had announced top-line results from the BATURA trial’s prespecified interim analysis in October last year, wherein Airsupra demonstrated a significant and clinically meaningful reduction in the risk of severe exacerbations versus albuterol alone in patients 12 and older with intermittent or mild persistent asthma on a short-acting beta2-agonist (SABA) alone, or as-needed SABA accompanied by either low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance therapy.Full results, also published in the NEJM, showed that AstraZeneca’s inhaled combination therapy met the study’s primary endpoint, cutting the risk of severe exacerbations by 47% compared with albuterol alone. This “unprecedented” efficacy outcome at a time point prompted an early termination of the trial as reported earlier.On a key secondary endpoint, patients receiving Airsupra experienced 63% lower exposure to systemic corticosteroids over the treatment period versus albuterol alone. Similar gains on all endpoints were seen in a subgroup of adult patients. Meanwhile, the safety profile of inhaled therapy remained consistent with previous studies, showing no clinically meaningful differences between treatment groups.“We hope these comprehensive results accelerate the use of anti-inflammatory rescue therapy as the preferred standard of care, in line with recommendations from the Global Initiative for Asthma,” remarked Sharon Barr, head of biopharmaceuticals R&D at AstraZeneca.Co-developed by AstraZeneca and Avillion, Airsupra secured FDA approval in 2023 as rescue medication for as-needed treatment of bronchoconstriction and exacerbation risk reduction in adults with asthma, but was turned down by the regulator for use in a younger population. Jefferies analysts predicted a peak sales of $1.8B for Airsupra after the results top-lined last year.