The US Food and Drug Administration (FDA) has approved AstraZeneca and Avillion’s Airsupra (albuterol/budesonide), to treat asthma.

Previously known as PT027, Airsupra is a pressurised metered-dose inhaler (pMDI), fixed-dose combination rescue medication.

It comprises short-acting beta2-agonist (SABA) albuterol and anti-inflammatory inhaled corticosteroid (ICS) budesonide.

Airsupra has been approved for the as-needed treatment or prevention of bronchoconstriction and for reducing the exacerbations risk in asthma patients aged 18 years and above.

It is claimed to be the first and only rescue medication approved for this indication in the country.

The drug is being developed by AstraZeneca and Avillion under a co-development agreement signed in March 2018.

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AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “With patients experiencing more than ten million asthma exacerbations each year in the US and uncontrolled asthma expected to cost the US economy billions of dollars in direct medical costs alone over the next 20 years, today’s positive decision is good news for those adults with asthma who make up more than 80% of asthma patients in the US.

“Physicians will be able to offer their patients Airsupra, an important new rescue treatment that reduces the risk of asthma exacerbations.”

The regulatory approval was based on the data obtained from the Phase III MANDALA and DENALI trials.

Airsupra significantly reduced severe exacerbations risk compared to albuterol in moderate to severe asthma patients in the MANDALA trial.

It also showed a reduction in mean annualised total systemic corticosteroid exposure significantly compared to albuterol, which is the trial’s secondary endpoint.

The therapy significantly improved lung function in the DENALI trial against albuterol and budesonide individually in mild to moderate asthma patients.

It also demonstrated consistent safety and tolerability in both trials with the known profiles of the components.