Asthma treatment approved by FDA after success of trial program
The program made up of four studies involving 4,000 patients was conducted by Avillion under a co-development agreement with AstraZeneca. It was upon the success of these that the FDA approval was granted. The first two included the Mandala and Denali trials.
The treatment is made of two small molecules – albuterol and budesonide formerly known as PT027 for the treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older. It is used as and when it is needed.
Airsupra is a pressurised metered-dose inhaler (pMDI) fixed-dose combination rescue medication containing the short-acting beta2-agonist albuterol and anti-inflammatory inhaled corticosteroid (ICS) budesonide.
Under its 2018 agreement, Avillion had regulatory responsibility including filing the New Drug Application (NDA) through to FDA approval in the US. Following this approval, AstraZeneca has the option, upon making certain financial payments to Avillion, to commercialise Airsupra in the US.
Bradley Chipps, medical director of capital allergy and respiratory Disease Center, US, 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.”
Avillion says it has a 100% success rate with clinical co-development partnerships for the global pharmaceutical and biotech industry.
The Mandala trial showed that 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 were published in the New England Journal of Medicine in May 2022.
The Denali trial showed that 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 showed they 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 randomised phase 2b decentralised trial to further assess the role of Airsupra in reducing the risk of asthma exacerbations.
The Airsupra clinical co-development programme was funded by Blackstone Life Sciences, Royalty Pharma and Abingworth.
Allison Jeynes, MD, chief executive officer of Avillion, said: “We’re delighted that our clinical co-development programme 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.
"We’ve had an excellent working relationship with AstraZeneca and are excited to continue our partnership with the BATURA phase 2b study, which is looking to continue building the evidence base of Airsupra to reduce the risk of asthma exacerbations.”
