Avillion announces U.S. approval of AZ's Airsupra (PT027) as new rescue treatment for asthma

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  • Airsupra is the first rescue medication approved in the U.S. for as-needed use to reduce risk of asthma exacerbations.
  • Approval based on successful phase III trial program conducted by Avillion in more than 4,000 patients under an exclusive clinical co-development agreement with AstraZeneca.

Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical candidates from proof-of-concept through to regulatory approval, announces that the U.S. FDA has approved AstraZeneca's Airsupra (albuterol/budesonide, 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.

Airsupra 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 program 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.

Under its 2018 agreement, Avillion had regulatory responsibility including filing the New Drug Application through to FDA approval in the U.S. Following this approval, AstraZeneca has the option, upon making certain financial payments to Avillion, to commercialize Airsupra in the U.S.

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.

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.


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