FDA Committee Recommends PT027 as Rescue Treatment for Asthma in Individuals 18 Years of Age and Older

FDA committee voted that trial data do not support the benefits outweighing the risks in patients aged 12 to 17 years and children aged 4 to 11 years for the use of albuterol/budesonide in the treatment of asthma.

The FDA Pulmonary-Allergy Drugs Advisory Committee voted 16 to 1 in favor of albuterol/budesonide (PT027; AstraZeneca) for the treatment of asthma in individuals 18 years of age and older after data indicate that the benefits outweigh the risks. However, the FDA committee voted 9 to 8 that trial data do not support the benefits outweighing the risk in patients aged 12 to 17 years.

Among children 4 to 11 years of age, the committee voted 16 to 1 that the data do not support the benefits outweighing the risks for the use of albuterol/budesonide for the treatment of asthma.

“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,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, in a press release. “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.”

Albuterol/budesonide is a potential first-in-class, pressurized metered-dose inhaler (pMDI), short acting beta2 agonist/inhaled corticosteroid to be taken when necessary for the treatment of asthma. Albuterol/budesonide is an inhaled, fixed-dose combination rescue medication containing albuterol—or salbutamol—and budesonide, a corticosteroid. The medication is being developed using the Aerospace delivery technology from AstraZeneca.

“Millions of people with asthma rely on their albuterol rescue inhaler to alleviate acute symptoms, but this does not treat the underlying inflammation, leaving patients at risk of severe asthma exacerbations, regardless of their disease severity or level of control. If approved, PT027 could transform the current rescue treatment approach,” said Bradley E. Chipps, past president of the American College of Allergy, Asthma & Immunology and medical director of the Capital Allergy & Respiratory Disease Center in Sacramento, in a press release.

The submission was based on results from the MANDALA, DENALI, and TYREE phase 3 trials. In the DENALI trial, albuterol/budesonide significantly improved lung function compared to the individual sections, albuterol, and budesonide, in patients with mild to moderate asthma.

In the MANDALA phase 3 trial comparing the drug with albuterol rescue, PT027, at the 180-mcg albuterol/160 mcg budesonide dose, reduced the risk of severe exacerbation by 27% in both adolescents and adults. The investigators randomized individuals to receive either PT027 or albuterol rescue on top of their usually prescribed maintenance inhaled corticosteroid, with or without additional controller medicines.

In the secondary endpoints, PT027 demonstrated a 33% reduction in mean annualized total systemic corticosteroid exposure and a 24% reduction in annualized severe exacerbation rate.

A numerically higher odds of individuals experiencing an improvement in quality of life and symptom control was observed after 34 weeks of treatment with PT027 compared with the albuterol rescue.

Additionally, the safety and tolerability of albuterol/budesonide in these trials were consistent with the known profiles of them. Adverse events (AEs) were similar across the treatment groups in the MANDALA trial and were consistent with the known safety profile of the individual components. The most common AEs were headaches and nasopharyngitis.

REFERENCE

PT027 recommended by FDA Advisory Committee as new rescue treatment for asthma. AstraZeneca. November 9, 2022. Accessed November 9, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/fda-advisory-committee-recommends-pt027-in-asthma.html