AstraZeneca, Avillion Land FDA Approval for First of Its Kind Asthma Inhaler

An asthma rescue inhaler from partners AstraZeneca and Avillion has 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, which voted 16-1 in November that the inhaler’s benefits outweigh its risks in adults. But a separate vote regarding adolescents was much closer and for children age 4 to 11, the vote was decidedly against a favorable recommendation. FDA approval of the product, known in development as PT027, covers only adults 18 and older. The inhaler will be commercialized under the name “Airsupra.”

Airsupra is a pressurized, metered-dose inhaler that administers a fixed dose of two drugs: albuterol and budesonide. Albuterol is a widely used inhalable medication that opens up airways. Budesonide is a corticosteroid whose anti-inflammatory activity is used to treat various conditions. Airsupra delivers an inhalable form of that drug in combination with albuterol. According to the FDA, Airsupra is the first such combination product to win approval as a “reliever treatment,” which are sometimes also called rescue medications.

Albuterol rescue inhalers are already available to asthma patients. These products alleviate acute systems but do not address the underlying inflammation, according to Bradley Chipps, past president of the American College of Allergy, Asthma & Immunology and Medical Director of Capital Allergy & Respiratory Disease Center in Sacramento, California.

“The approval of Airsupra means that for the first time, adults with asthma in the U.S. have a rescue treatment to manage both their symptoms and the inflammatory nature of their disease,” Chipps said in a prepared statement.

The FDA decision is based on the results of a Phase 3 clinical trials that tested the inhaler in patients with moderate-to-severe asthma. Results showed the drug combination from Airsupra significantly reduced the risk of severe exacerbations compared to albuterol alone. The most common side effects reported from the trials included headache, oral thrush, cough, and difficulty speaking. Data were 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 pharma giant, signed a deal to co-develop the inhaler. Specific financial terms were not disclosed but Avillion was responsible for financing the development of the program through regulatory approval. Avillion’s business model is to shoulder all financial risk of developing a product but receive milestone and royalty payments from a pharma partner if the product reaches the market. Other Avillion partners include Pfizer and Merck KGaA.

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

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