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# Panel Backs AstraZeneca Asthma Product in Adults
- URL: https://www.fdaweb.com/panel-backs-astrazeneca-asthma-product-in-adults/
- Published: 2022-11-09T12:00:00.000Z
- Updated: 2026-09-14T18:05:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153164

FDA’s Pulmonary-Allergy Drugs Advisory Committee has voted 16 to 1 to support approval of an AstraZeneca NDA for PT027 (albuterol/budesonide) for treating asthma in those aged 18 years and older, but it did not support (16 to 1 vote against) the product’s use in children and adolescents aged four to 17 years (9 to 8 vote). The company describes PT027 as a potential first-in-class, pressurized metered-dose inhaler, fixed-dose combination rescue medication containing albuterol, a short-acting beta2-agonist, and budesonide, an anti-inflammatory inhaled corticosteroid. The product is being developed by AstraZeneca and Avillion.

The NDA was based on data from the MANDALA, DENALI and TYREE Phase 3 trials. For example, in MANDALA, the combination drug significantly reduced the risk of severe exacerbations compared to albuterol in patients with moderate to severe asthma when used as an as-needed rescue medication in response to symptoms, according to the company. The study enrolled 3,132 patients but there were only 100 adolescents and 83 children.

Some panel members were concerned about extrapolating adult data to determine pediatric acceptance. They suggested more data would be needed before recommending the drug’s use in the younger subpopulations.