AstraZeneca and Avillion’s asthma rescue treatment granted FDA approval

AstraZeneca (AZ) and Avillion’s Airsupra, formerly known as PT027, has been approved by the US Food and Drug Administration (FDA) as the first and only rescue medication for as-needed use to reduce the risk of asthma exacerbations for adults with asthma.

The companies’ fixed-dose, pressurised, metered-dose inhaler contains a combination of albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid.

“Current albuterol rescue inhalers alleviate acute symptoms, but do not treat the underlying inflammation in asthma,” explained Bradley Chipps, past president of the American College of Allergy, Asthma and Immunology and medical director of Capital Allergy and Respiratory Disease Center in Sacramento, US.

“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,” he said.

The FDA’s decision was based on positive results from the MANDALA and DENALI phase 3 trials.

In MANDELA, Airsupra demonstrated a significant reduction in the risk of severe exacerbations compared to albuterol in patients with moderate-to-severe asthma when used as an as-needed rescue medication.

AZ and Avillion’s treatment also met the trial’s secondary endpoint of annualised total systemic corticosteroid exposure, demonstrating a significant reduction compared to albuterol.

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 these trials were consistent with the known profiles of the components, AZ reported.

Asthma is a chronic, inflammatory respiratory disease with variable symptoms that affects as many as 262 million people worldwide, including over 25 million in the US.

Patients are at risk of severe exacerbations regardless of their disease severity, adherence to treatment or level of control. There are an estimated 136 million asthma exacerbations globally per year, including more than ten million in the US.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AZ, said: “Today’s positive decision is good news for those adults with asthma, who make up more than 80% of asthma patients in the US.”