AstraZeneca wins adult-only approval for asthma inhaler

Jan. 11, 2023

The U.S. FDA has approved AstraZeneca’s first-in-class, pressurized metered-dose inhaler for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations — but only for people with asthma aged 18 years and older.

Branded Airsupra, the fixed-dose combination rescue medication contains albuterol (a short-acting beta2-agonist) and budesonide (an anti-inflammatory inhaled corticosteroid).

AstraZeneca co-developed the rescue treatment with London-based Avillion. Per a 2018 agreement, Avillion had regulatory responsibility, including filing the New Drug Application, through to FDA approval. After that, AstraZeneca was given the option to commercialize Airsupra in the U.S.

The U.S. approval was based on positive results from a global phase 3 clinical trial program comprising four studies involving more than 4,000 patients (including the MANDALA and DENALI trials1,2), which was conducted successfully by Avillion under an exclusive clinical co-development agreement with AstraZeneca.

Back in Nov., the Pulmonary-Allergy Drugs Advisory Committee voted 16 to 1 that the data from these trials supported a favorable benefit risk assessment for the  for the treatment of asthma in people aged 18 years and older. However, in adolescents aged 12-17 years, the AdComm voted 9 to 8 that the data do not support a favorable benefit risk assessment. In children aged 4-11 years, the AdComm voted 16 to 1 against the treatment.

Among the 3,132 patients enrolled in the largest trial, MANDALA, there were only 100 adolescents and 83 children. According to Avillion in an AdComm briefing doc, this "precluded meaningful statistical inference of treatment benefits."  And the AdComm and the FDA agreed.

For adults, the new inhaler has the potential to transform the current rescue treatment approach.

“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," said Bradley E. Chipps, former president of the American College of Allergy, Asthma & Immunology and medical director of Capital Allergy & Respiratory Disease Center.