Avillion LLP announces that the US Food and Drug Administration (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, pressurised 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 US 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 trials1,2), which was conducted successfully by Avillion under an exclusive clinical co-development agreement with AstraZeneca.

The co-development partnership between AstraZeneca and Avillion has recently expanded to include the BATURA study, a randomised Phase IIIb decentralised trial to further assess the role of Airsupra in reducing the risk of asthma exacerbations.