FDA approves Airsupra, fixed-dose combination rescue asthma inhaler for adults
Click Here to Manage Email Alerts
The FDA approved a pressurized metered-dose inhaler with a fixed-dose combination of albuterol and budesonide for use as rescue medication among patients with asthma aged 18 years and older, according to a manufacturer-issued press release.
According to the release, the FDA approved albuterol/budesonide (Airsupra; Avillion, AstraZeneca), previously known as PT027, in this patient population for use as an as-needed treatment to prevent bronchoconstriction and to decrease the risk for asthma exacerbations.
This approval follows the FDA’s Pulmonary-Allergy Drug Advisory Committee recommendations, which, as Healio previously reported, in November 2022 voted 16-1 in favor of approval for those with asthma aged at least 18 years.
The current approval was based, in part, on data from both the MANDALA and DENALI phase 3 trials. In the former, combined 180 µg albuterol, a short-acting beta2-agonist, and 160 µg budesonide, an anti-inflammatory inhaled corticosteroid, decreased the risk for severe asthma exacerbations and annualized total systemic corticosteroid exposure among patients with moderate to severe asthma compared with albuterol alone.
Similarly, patients with mild to moderate asthma taking the combination inhaler showed better lung function compared with those assigned either albuterol or budesonide alone in the DENALI trial.
Frequent adverse events in both trials associated with albuterol/budesonide included headache, oral candidiasis, cough and dysphonia, according to the release.
“With patients experiencing more than 10 million asthma exacerbations each year in the U.S. and uncontrolled asthma expected to cost the U.S. economy billions of dollars in direct medical costs alone over the next 20 years, today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the U.S.,” Mene Pangalos, PhD, FRSB, FMedSci, executive vice president of biopharmaceuticals R&D at AstraZeneca, said in the release. “Physicians will be able to offer their patients Airsupra, an important new rescue treatment that reduces the risk of asthma exacerbations.”
Perspective
Back to Top
The beauty of this newly approved combination therapy — data for which has been reinforced by the MANDALA and DENALI studies — is that when faced with lack of asthma control, studies demonstrated that dynamic and escalated doses of controller therapy/ICS can have beneficial effects. Thus, with use of rescue SABA, the addition of ICS can be game changing. Further, there are data that indicate the frequency of ICS use may also be impactful.
That’s the science — we must then consider real-world data. A study by Partridge and colleagues demonstrated that in the real world, when faced with asthma exacerbation, most patients feel comfort in adjusting their dose of asthma medications; however, unfortunately, they usually stop or decrease their ICS while they increase their SABA. Thus, this combination therapy is a no brainer. It induces adherence through positive reinforcement.
My colleague Larry Borish, MD, and I wrote a paper regarding the science and practical utility of this approach that is being published in Annals of Allergy, Asthma & Immunology.
References:
Oppenheimer J, et al. Ann Allergy Asthma Immunol. 2023;doi:10.1016/j.anai.2023.01.007.
Papi A, et al. N Engl J Med. 2022;doi:10.1056/NEJMoa2203163.
Partridge MR, et al. BMC Pulm Med. 2006;doi:10.1186/1471-2466-6-13.
Read more about
Click Here to Manage Email Alerts