AstraZeneca and Avillion have received the US Food and Drug Administration (FDA) approval for Airsupra (albuterol/budesonide) to treat a type of asthma in adults.
Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication containing albuterol, a short-acting beta-agonist (SABA), and budesonide, a corticosteroid.
Previously known as PT027, the drug is indicated for the as-needed treatment or prevention of bronchoconstriction and reduces the risk of exacerbations in adults with asthma.
Airsupra is being jointly developed by AstraZeneca and Avillion, under a global clinical development partnership signed in March 2018.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “Today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the US.
“Physicians will be able to offer their patients Airsupra, an important new rescue treatment that reduces the risk of asthma exacerbations.”
The FD approval is supported by results from the Phase 3 MANDALA and DENALI trials.
In the MANDALA trial, Airsupra has significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma.
The drug showed a significant reduction in mean annualised total systemic corticosteroid exposure compared to albuterol, which is the secondary endpoint.
In the DENALI trial, Airsupra significantly improved lung function compared to albuterol and budesonide in patients with mild to moderate asthma.
The drug showed consistent safety and tolerability in both trials with the known profiles of the components, with the most common adverse events such as headache, oral candidiasis, cough and dysphonia.
Capital Allergy and Respiratory Disease Centre medical director Bradley E Chipps said: “Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma.
“The approval of Airsupra means that for the first time, adults with asthma in the US have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease.”
