AstraZeneca (AZ) and Avillion’s PT027 (albuterol/budesonide) has been recommended by the US Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) for the treatment of asthma in patients aged 18 years and older, the company announced.
The committee voted against the use of PT027 in adolescents aged 12 to 17 years and in children aged four to 11 years.
PT027 is being developed by AZ and Avillion as a potential first-in-class, pressurised metered-dose inhaler, fixed-dose combination rescue medication in the US containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid.
The FDA accepted the New Drug Application for PT027 in the first half of 2022 and set a Prescription Drug User Fee Act date for the first half of 2023.
The submission was based on results from three phase 3 trials: MANDALA, DENALI and TYREE. In MANDALA, PT027 was shown to significantly reduce the risk of severe asthma exacerbations compared to albuterol in patients with moderate-to-severe asthma when used as an as-needed rescue medication in response to symptoms
Meanwhile, in DENALI, PT027 significantly improved lung function compared to the individual components, albuterol and budesonide, in patients with mild-to-moderate asthma.
The safety and tolerability of PT027 in these trials were consistent with the known profiles of the components, AZ reported.
Patients with asthma are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control. There are an estimated 176 million asthma exacerbations globally per year, including more than ten million in the US. These are physically threatening and emotionally significant for many patients and can be fatal.
Inflammation is central to both asthma symptoms and exacerbations. Many patients experiencing asthma symptoms use a SABA, such as albuterol as a rescue medicine. However, taking a SABA alone does not address inflammation, AZ outlined, leaving patients at risk of severe exacerbations, which can result in impaired quality of life, hospitalisation and frequent oral corticosteroid use.
“Millions of people with asthma rely on their albuterol rescue inhaler to alleviate acute symptoms, but this does not treat the underlying inflammation, leaving patients at risk of severe asthma exacerbations, regardless of their disease severity or level of control,” explained Bradley Chipps, past president of the American College of Allergy, Asthma & Immunology and medical director of the Capital Allergy & Respiratory Disease Center in Sacramento, US.
He added that, if approved, PT027 could “transform the current rescue treatment approach”.