After breaking through the blockbuster sales threshold in 2025, AstraZeneca’s three-in-one inhaler Breztri Aerosphere has passed another crucial milestone as it chips in on the British drugmaker’s goal to reach $80 billion in revenues by 2030.
On Tuesday, the FDA approved Breztri in its second indication, clearing the triple combination therapy of budesonide, glycopyrrolate and formoterol fumarate as a maintenance treatment for asthma in adults and kids ages 12 and older. Breztri was first greenlit in the U.S. in 2020 as a maintenance treatment for chronic obstructive pulmonary disease (COPD).
The new nod will unlock a substantial market for Breztri, which is one of several respiratory products driving significant sales ambitions at AstraZeneca. Last year, the drug surpassed the billion-dollar sales threshold for the first time, with revenues growing (PDF) 22% at constant currencies to nearly $1.2 billion.
In turn, the drug ranks among the roster of newer AZ products enlisted in the British pharma’s campaign to hit an impressive $80 billion in sales by the end of the decade. As of January, that target still appeared “very much within reach,” the company’s CFO Aradhana Sarin said at the J.P. Morgan Healthcare Conference in San Francisco.
The FDA signed off on Breztri’s new use after reviewing data from a pair of phase 3 studies, KALOS and LOGOS, which assessed the triple inhaler in a broad population of asthma patients, both with or without a recent asthma exacerbation.
In the trials, Breztri charted a statistically significant and clinically meaningful improvement in lung function compared with a dual-combination control consisting of an inhaled corticosteroid and long-acting beta2-agonist (ICS/LABA), AZ said. The drug also demonstrated rapid onset of action, plus significant improvement from baseline in lung function within five minutes of the first dose.
There are around 27 million people living with asthma in the U.S., around half of whom struggle to control their condition on dual therapies, per AZ’s reckoning. The company added that around 10 million asthma attacks occur in the U.S. each year.
As a maintenance therapy, Breztri is not indicated to relieve sudden breathing problems as a stand-in for a rescue inhaler, AZ noted.
Widely available in COPD around the globe, Breztri is also in the running for asthma approvals in places like the European Union, Japan and China.
Beyond Breztri, Fasenra and the Amgen-partnered Tezspire form the other major pillars of AstraZeneca’s respiratory empire.