Avillion LLP says the US Food and Drug Administration (FDA) has approved AstraZeneca’s Airsupra 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.
Airsupra, (albuterol/budesonide, formerly known as PT027) is a first-in-class, 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).
The U.S. approval was based on positive results from a global phase III clinical trial programme for Airsupra comprising four studies involving more than 4,000 patients (including the MANDALA and DENALI trials), which was conducted successfully by Avillion under an exclusive clinical co-development agreement with AstraZeneca.
Option to commercialize for AstraZeneca
Under a 2018 agreement, Avillion had regulatory responsibility including filing the new drug application (NDA) through to FDA approval in the U.S. Following this approval, AstraZeneca has the option, upon making certain financial payments to Avillion, to commercialize Airsuprain in the U.S.
This milestone continues Avillion’s 100% successful rate in clinical co-development partnerships for the global pharmaceutical and biotech industry.
In MANDALA, Airsupra significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms. The results from the MANDALA trial were published in the New England Journal of Medicine in May 2022.
In DENALI, Airsupra significantly improved lung function compared to the individual components, albuterol and budesonide, in patients with mild to moderate asthma. The safety and tolerability of Airsupra in both trials were consistent with the known profiles of the components, with the most common adverse events including headache, oral candidiasis, cough and dysphonia.
Co-development
The co-development partnership between AstraZeneca and Avillion has recently expanded to include the BATURA study, a randomized phase IIIb decentralized trial to further assess the role of Airsupra in reducing the risk of asthma exacerbations.
The Airsupra clinical co-development program was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth.
Bradley E. Chipps, past president of the American College of Allergy, Asthma & Immunology, and medical director of the Capital Allergy & Respiratory Disease Center in Sacramento, U.S., said: “People with asthma are at risk of severe exacerbations regardless of their disease severity or level of control.
“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.”
Allison Jeynes, chief executive officer of Avillion, said: “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. The Airsupra approval continues our 100% success rate facilitating clinical co-development programmes with pharma companies, demonstrating the strong value our innovative model can provide to partners and the excellence and dedication of our international team.”