AstraZeneca's Breztri Shows Promise in Asthma Trials, Paving Way for Label Expansion

AstraZeneca has announced positive results from two pivotal Phase 3 trials evaluating Breztri Aerosphere as a potential treatment for asthma, marking a significant step towards a label expansion for the triple-combination inhaler.

Trial Success Bolsters AstraZeneca's Respiratory Portfolio

The KALOS and LOGOS studies, which enrolled a total of 4,434 patients with uncontrolled asthma, met their primary endpoints. Both trials demonstrated statistically significant and clinically meaningful improvements in lung function compared to dual-drug combinations of inhaled corticosteroid (ICS) and long-acting beta2-agonist (LABA) maintenance treatments.

Breztri Aerosphere, a fixed-dose combination of budesonide (corticosteroid), formoterol fumarate (LABA), and glycopyrronium (long-acting muscarinic antagonist), was first approved for chronic obstructive pulmonary disorder (COPD) in 2020. The positive trial results in asthma could potentially expand its use to a broader patient population.

Dr. Alberto Papi from St. Anna University Hospital in Ferrara, Italy, commented on the trial outcomes: "The results from the KALOS and LOGOS trials are exciting and demonstrate the potential of Breztri to evolve the standard of care to more effectively treat asthma in a single inhaled triple therapy."

Market Performance and Future Prospects

Breztri has shown strong market performance, with sales reaching $300 million in the first quarter of 2025, representing a 37% year-over-year increase. This growth trajectory positions the drug to potentially achieve blockbuster status for the first time this year.

AstraZeneca aims to leverage these positive trial results to boost Breztri's market position further. The company has set an ambitious sales target of $3 billion to $5 billion annually for the inhaler. A successful label expansion into asthma treatment could significantly contribute to achieving this goal, given that asthma affects approximately 262 million people worldwide.

Competitive Landscape in Respiratory Therapeutics

Breztri's development comes as part of AstraZeneca's broader strategy to strengthen its respiratory disease portfolio. The company is also advancing other treatments such as Fasenra and Tezspire, both already approved for asthma and under consideration for COPD label expansions.

In the competitive landscape of respiratory therapeutics, Breztri trails behind GSK's Trelegy Ellipta, which was approved for COPD in 2017 and asthma in 2020. Trelegy generated sales of $3.5 billion in 2024, while forecasts project Breztri's sales to reach $2.3 billion by 2030.

As AstraZeneca prepares to share data from the KALOS and LOGOS studies with regulatory authorities and at upcoming medical meetings, the pharmaceutical industry watches closely to see how this development may reshape the treatment landscape for asthma and impact the competitive dynamics in the respiratory therapeutics market.