The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for PT027 for the as-needed treatment or prevention of bronchoconstriction and for the prevention of exacerbations in patients with asthma 4 years of age and older.
PT027 is an inhaled, fixed-dose combination of albuterol, a short-acting beta2-agonist, and budesonide, an inhaled corticosteroid (ICS). The NDA submission is supported by data from the multicenter, randomized, double-blind, parallel-group phase 3 MANDALA trial (ClinicalTrials.gov Identifier: NCT03769090), which evaluated the efficacy and safety of albuterol/budesonide, used as an as-needed rescue medicine, on the time to first severe asthma exacerbation in 3132 patients aged 4 years and older with moderate to severe asthma who were receiving ICS with or without additional medications.
Patients were randomly assigned 1:1:1 to receive albuterol/budesonide 180mcg/160mcg (excluding children aged 4-11 years), albuterol/budesonide 180mcg/80mcg, or albuterol sulfate metered-dose inhaler 180mcg, taken as an as-needed rescue medication in response to symptoms.
Findings demonstrated that treatment with albuterol/budesonide 180mcg/160mcg reduced the risk of severe asthma exacerbation by 26% when compared with albuterol alone (hazard ratio [HR], 0.74; 95% CI, 0.62-0.89; P =.001). The HR for albuterol/budesonide 180mcg/80mcg, as compared with albuterol alone, was reported to be 0.84 (95% CI, 0.71-1.00; P =.052). Adverse events were observed to be similar between the 3 treatment groups.
The combination treatment was also evaluated in the phase 3 DENALI trial (ClinicalTrials.gov Identifier: NCT03847896), which showed that patients treated with albuterol/budesonide demonstrated statistically significant improvements in lung function compared with the individual components and placebo.
“Our clinical studies have demonstrated the strong potential of PT027 in providing a meaningful contribution to patient care in asthma, and we’re pleased to be making this NDA filing and reaching a key milestone in what continues to be an excellent partnership with AstraZeneca,” said Allison Jeynes, MD, CEO of Avillion. “We’re excited to continue working with AstraZeneca as PT027 progresses through the regulatory process, and as we prepare to launch the BATURA study as part of an expansion to the partnership.”
- US FDA accepts New Drug Application filed by Avillion for AstraZeneca’s PT027 for the as-needed treatment or prevention of symptoms in asthma patients. News release. Avillion LLP. Accessed May 31, 2022. https://www.prnewswire.com/news-releases/us-fda-accepts-new-drug-application-filed-by-avillion-for-astrazenecas-pt027-for-the-as-needed-treatment-or-prevention-of-symptoms-in-asthma-patients-301557384.html
- Papi A, Chipps BE, Beasley R, et al. Albuterol–budesonide fixed-dose combination rescue inhaler for asthma. N Engl J Med. Published online May 15, 2022. doi:10.1056/NEJMoa2203163