Who is this relevant for?
- Pharmaceutical buyers sourcing shortage medicines
- Hospitals managing supply risk
- Distributors monitoring sourcing opportunities
The FDA approved AstraZeneca's Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) as maintenance therapy for asthma in adults and children aged 12 and up. This is the first single-inhaler triple therapy approved for that age group.
The approval rests on two phase III trials, KALOS and LOGOS, which enrolled over 4,300 patients. Both studies showed improvements in lung function and a reduction in severe exacerbations compared with Symbicort, a dual therapy. At 24 weeks, morning pre-dose trough FEV1 improved by 71-91 mL with Breztri, and annualized severe exacerbations dropped by 18-20%.
Common adverse events include nasopharyngitis, pneumonia, and headache. The drug carries a boxed warning for status asthmaticus and risks associated with LABA overdose, oropharyngeal candidiasis, and adrenal suppression. Switching from systemic corticosteroids requires slow tapering to avoid adrenal insufficiency.
Breztri first gained approval for COPD in 2020. In asthma, it now competes with Trelegy Ellipta, which is approved only for adults 18 and older. The new indication extends triple therapy access to a younger patient population, potentially changing prescribing patterns and supply dynamics for hospitals and distributors.