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An asthma rescue inhaler from partners AstraZeneca and Avillion won FDA approval, giving patients the option of a single product that both manages symptoms and controls underlying inflammation. For AstraZeneca, the new product could breathe new life into the pharmaceutical giant’s respiratory portfolio.

The regulatory decision announced Wednesday follows the affirmative recommendation of an FDA advisory committee that voted 16-1 in November that the benefits of the inhaler outweigh the risks in adults. But a separate vote on adolescents was much closer and for children aged 4 to 11 the vote was strongly against a favorable recommendation. FDA approval for the product, known in development as PT027, covers only adults 18 and older. The inhaler will be marketed under the name “Airsupra”.

Airsupra is a pressurized metered dose inhaler that delivers a fixed dose of two medications: albuterol and budesonide. Albuterol is a widely used inhaled medicine that opens the airways. Budesonide is a corticosteroid whose anti-inflammatory activity is used to treat a variety of conditions. Airsupra supplies an inhaled form of this drug in combination with albuterol. According to the FDA, the product is the first such combination product to receive approval as a “palliative treatment,” sometimes called a rescue drug.

Rescue albuterol inhalers are now available for asthma patients. These products relieve acute systems but don’t address the underlying inflammation, according to Bradley Chips, past president of the American College of Allergy, Asthma and Immunology and medical director of the Capital Allergy & Respiratory Disease Center in Sacramento, California.

“The approval of Airsupra means that for the first time, adults with asthma in the US have a life-saving treatment to address both the symptoms and the inflammatory nature of their disease,” Chips said in prepared statement.

The FDA’s decision is based on the results of phase 3 clinical trials that tested the inhaler in patients with moderate to severe asthma. The results showed that the Airsupra inhaler drug combination significantly reduced the risk of severe exacerbations compared to albuterol alone. The most common side effects reported by the studies included headache, oral thrush, cough and difficulty speaking. The data was published last June in the New England Journal of Medicine.

AstraZeneca’s collaboration with London-based Avillion began in 2018. Pearl Therapeutics, a subsidiary of the pharmaceutical giant, signed a deal to co-develop the inhaler. Avillion was responsible for funding the development of the program through regulatory approval. Financial terms were not disclosed, but Avillion’s model is to take all the financial risk of developing a product but receive principal payments and royalties from a pharmaceutical partner if the product reaches the market. Other Avillion partners include Pfizer and Merck KGaA.

AstraZeneca now markets an asthma inhaler. Symbicort, which reported more than $2.7 billion in revenue in 2021, administers a combination of the drugs budesonide and formoterol. But this product is a “control drug” that is used for maintenance treatment, not rescue. Although Symbicort is currently the top seller in AstraZeneca’s respiratory and immunology portfolio, it is facing patent expiration. Airsupra gives the company a new product that can address the more than 21 million adults who have asthma and may be looking for alternatives to rescue inhalers.

Photo: Jackie Niam, Getty Images

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