- The Food and Drug Administration has approved AstraZeneca and Avillion’s respiratory drug Airsupra, making it the first medicine in the U.S. cleared to both ease asthma attack symptoms and reduce further exacerbations of the condition, the company said Wednesday.
- The agency based its decision on two major Phase 3 trials, including one published in The New England Journal of Medicine that found patients who used high-dose Airsupra had a 26% lower risk of exacerbations compared with the standard medication albuterol alone. Patients on a lower dose of the group also saw improvement over albuterol, though less striking.
- Formerly known as PT027, Airsupra will be available to patients 18 and older. In its approval, the FDA followed the advice of an expert panel, which in November backed the drug’s use for adults but not for children and adolescents. AstraZeneca at the time said it would work with the agency and development partner Avillion on next steps for younger patients.
Airsupra is part of a growing portfolio of new drugs that are helping offset wilting sales of older AstraZeneca respiratory medicines such as Pulmicort. It’s an essential therapeutic area for the British drugmaker; in the third quarter, respiratory and immunology drugs accounted for 14% of overall revenue.
The company’s current top-selling respiratory medicine, an inhaler called Symbicort, brought in $630 million in the third quarter. But it’s facing increased competition as patents expire, leaving AstraZeneca to depend more on products such as Fasenra, an asthma drug approved in 2017 that had revenue of $353 million in the third quarter.
AstraZeneca is also looking to a drug developed with Amgen called Tezspire, a biologic designed to ease airway inflammation in certain asthmatic patients. Before Tezspire won approval in late 2021, analysts predicted it could generate $1 billion in revenue by 2025. In the third quarter, Amgen reported sales of $55 million for the therapy.
Airsupra combines two drugs, albuterol and budesonide. Albuterol is commonly used in “rescue treatment” and does a good job relieving the symptoms that have asthmatic patients reaching for an inhaler during an attack. But the drug does little to address the inflammation in airways that causes the flareups. Airsupra is designed to treat both the acute symptoms and the underlying condition.
The dual action could “transform the current rescue treatment approach,” Bradley E. Chipps, past president of the American College of Allergy, Asthma & Immunology, said in an AstraZeneca statement in November.
Under a 2018 agreement with Avillion, AstraZeneca holds an option to market Airsupra in the U.S. upon making certain financial payments.