The AirAupra inhaler has been approved in the US as a treatment for asthma.
AirSupra combines two drugs that can be used as a “rescue inhaler” for exacerbations or “attacks.” It was also shown to help in dealing with inflammation that leads to the exacerbations.
The approval by the Food and Drug Administration was based on results from successful late-stage trials.
Airsupra is being developed by AstraZeneca and Avillion.
Bradley E. Chipps, past president of the American College of Allergy, Asthma & Immunology and medical director of Capital Allergy & Respiratory Disease Center in Sacramento, CA 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.”
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “With patients experiencing more than 10 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.”
Asthma affects as many as 262 million people worldwide. In the US more than 21 million adults have asthma, representing more than 80% of the total number of people with asthma. It is estimated that uncontrolled asthma cost the US economy an estimated $300 billion (in 2018 dollar values) in the next 20 years in direct medical costs, according to AZ.
The inhaler has not been approved by the FDA for those under age 18.
The drug comes as AstraZeneca faces expirations on patents for the Symbicort inhaler. Symbicort is authorized for patients 12 or over, but is not authorized as a rescue or quick-relief inhaler.
AstraZeneca employs 1,500 in Delaware.
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