FDA Approves Albuterol/Budesonide as First-in-Class Asthma Rescue Treatment

US Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) has approved albuterol/budesonide (Airsupra), formerly known as PT027, 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.

The rescue medication is the first and only approved in the US for the as-needed use to reduce risk of asthma exacerbations. The medication is a pressurized metered dose-inhaler (pMDI), fixed-dose combination rescue medication, containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS).

Its approval was based on a successful Phase III trial program conducted by Avillion LLP in over 4,000 patients under an exclusive clinical co-development agreement with AstraZeneca. This Phase 3 program included the MANDALA and DENALI trials.

“People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control,” said Bradley E. Chipps, Past President of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in a statement. “Current albuterol rescue inhalers alleviate acute symptoms, but not 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.”

Under a 2018 agreement, Avillion had regulatory responsibility in filing the New Drug Application (NDA) through to FDA approval in the US. After this approval, AstraZeneca has the option to commercialize Airsupra in the US. As per the company, this approval has continued Avillion’s 100% successful rate in clinical co-development partnerships.

Results from the MANDALA trial suggest albuterol/budesonide significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-need rescue medication in response to symptoms. The DENALI trial reported albuterol/budesonide significantly improved lung function compared to the individual components in patients with mild to moderate asthma.

Both trials indicated the safety and tolerability of albuterol/budesonide were consistent with the known profiles of the components, according to the statement. The most common adverse events reported included headache, oral candidates, cough, and dysphoria.

"We're delighted that our clinical co-development program with AstraZeneca has been successful and that Airsupra has been approved in the US as a new treatment option for asthma patients,” said Allison Jeynes, MD, Chief Executive Officer, Avillion in a statement. “The Airsupra approval continues our 100% success rate facilitating clinical co-development programs with pharma companies, demonstrating the strong value our innovative model can provide to partners and the excellence and dedication of our international team.”

The co-development partnership between AstraZeneca and Avillion has recently expanded to include the randomized BATURA Phase IIIb decentralized study to further assess the role of albuterol/budesonide in risk reduction of asthma exacerbations.