FDA Approves Breztri as First Single-Inhaler Triple Therapy for Asthma
The FDA approved AstraZeneca's Breztri Aerosphere as the first and only single-inhaler triple-combination therapy for asthma in patients aged 12 and older. The approval addresses a major unmet need, as about half of asthma patients remain inadequately controlled on dual therapy.
FDA Breakthrough in Respiratory Care
On April 28, 2026, AstraZeneca's fixed-dose triple-combination inhaler Breztri Aerosphere received FDA approval for the maintenance treatment of asthma in adults and pediatric patients aged 12 and older. The approval makes Breztri the only single-inhaler triple therapy available for asthma in the US.
Treatment Composition
Breztri combines budesonide, glycopyrrolate, and formoterol fumarate delivered via the Aerosphere pressurized metered-dose inhaler.
Clinical Need
Asthma affects an estimated 262 million people worldwide, including 27 million in the US, and approximately half of those patients remain inadequately controlled on dual therapy.