The US Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has recommended AstraZeneca’s PT027 for the treatment of asthma in people aged 18 years and older. The Committee has voted 9 to 8 for adolescents aged 12 to 17 years, and the data do not support a favourable risk assessment for the use of PT027 to treat asthma.
In 4-to-11 year children, the Committee has voted 16 to 1 that the data do not support a favourable risk assessment for the use of PT027 to treat asthma. AstraZeneca’s PT027 is a potential first-in-class fixed-dose combination rescue medication in the United States containing albuterol, a short-acting beta2-agonist (SABA), and budesonide, an anti-inflammatory inhaled corticosteroid (ICS), and it is currently being developed by Avillion and AstraZeneca.
In the first half of 2022, the US FDA will have accepted the New Drug Application (NDA) for PT027, and will set a Prescription Drug User Fee Act date for the first half of 2023. Millions of people with asthma mainly rely on the albuterol rescue inhaler to alleviate acute symptoms, but PT027 does not treat the underlying inflammation, leaving the patients at risk of serious asthma exacerbations. If PT027 is approved, it could transform the current approach of rescue treatment.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AstraZeneca, said that they are happy that the US FDA’s PADAC has recognized the potential for PT027 to deliver important benefits for people with asthma, as a treatment option in the United States.