The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee voted in favor (16 to 1) of the use of PT027 (albuterol/budesonide fixed-dose combination inhaler) for the as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients 18 years of age and older with asthma. However, the vote was mixed when the data were reviewed for younger patients.
In patients 12 to 17 years of age, the committee voted 9 “no” and 8 “yes” on the question of whether the evidence supported the use of PT027 in this patient population. As for patients 4 to 11 years old, the panel voted 16 “no” and 1 “yes” after making an assessment on the benefits and risks in this population.
While the application included data from 3 trials (MANDALA, DENALI, and TYREE), the panel focused mostly on the phase 3 MANDALA study (ClinicalTrials.gov Identifier: NCT03769090), which enrolled patients aged 4 years and older with moderate to severe asthma who were receiving an inhaled corticosteroid with or without additional medications.
Findings demonstrated that treatment with PT027 at the 180mcg albuterol/160mcg budesonide dose reduced the risk of severe asthma exacerbation by 27% when compared with albuterol alone (hazard ratio, 0.73; 95% CI, 0.61-0.88; P <.001); however, in the 2 pediatric subgroups, there were uncertainties with respect to the efficacy results due to the small sample size.
Commenting on the vote, Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “We are pleased that the Pulmonary-Allergy Drugs Advisory Committee has recognized the potential for PT027 to deliver important benefits for people with asthma, as a first-in-class treatment option in the US. We look forward to working with our partner Avillion and the FDA to progress the application and discuss next steps, including for adolescents and children.”
Although not bound by the committee’s recommendations, the FDA does take them into consideration when making decisions on approval. If approved, PT027 would be the first inhaled, fixed-dose combination rescue medication containing a short-acting beta2-agonist and a corticosteroid.
- PT027 recommended by FDA advisory committee as new rescue treatment for asthma. News release. November 9, 2022. https://www.businesswire.com/news/home/20221109005402/en/PT027-Recommended-by-FDA-Advisory-Committee-as-New-Rescue-Treatment-for-Asthma
- FDA Briefing Document. Budesonide/albuterol sulfate metered dose inhaler. Accessed November 9, 2022. https://www.fda.gov/media/162912/download