AstraZeneca's two late-stage trials enrolled both current and former smokers, spanning all blood eosinophil counts and every stage of lung function impairment. In the primary group of former smokers, tozorakimab cut moderate exacerbations by 29% and severe episodes by 34% versus placebo on top of inhaled standard of care. In the broader population that included current and former smokers, moderate flare-ups fell 30% and severe events 29% compared with placebo.
Subgroup findings by eosinophils showed reductions of 23% for patients below 150, 34% for those at or above 150, and 43% for those at or above 300. The injection is administered every four weeks.
COPD is a progressive disease that narrows airways and makes breathing tough. AstraZeneca estimates 16 million to 26 million Americans, many undiagnosed, live with COPD, which it says ranks as the No. 5 cause of death in the U.S.
Existing COPD biologics, Regeneron and Sanofi's Dupixent and GSK's Nucala, are used mainly in patients with high eosinophil counts. Ruud Dobber, president of AstraZeneca's biopharmaceuticals unit, said the new drug's breadth could "really change the treatment paradigm because of its broad utility," and noted there is currently no biologic option for patients with eosinophils below 150. Major clinical guidelines generally view low eosinophil levels, especially under 100 to 150, as signaling a low chance of responding to inhaled therapies. Dr. Meilan Han, who leads pulmonary and critical care at University of Michigan Health and served as a study investigator, put it plainly: "There's still a huge number of patients who are not candidates for biologics with the current two approved drugs."
The science here matters. Tozorakimab blocks IL-33, a protein tied to inflammation and mucus production. After years of mixed results for IL-33 drugs, AstraZeneca argues its antibody takes a different tack by inhibiting two IL-33 pathways rather than one, aiming at inflammation, mucus, and airway damage. "Everybody thought it would fail."
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The company recently lifted its peak sales forecast for tozorakimab to more than $5 billion, saying that could help it get to $80 billion in revenue by 2030.
Regulatory momentum is building. Tozorakimab is under priority review at the Food and Drug Administration, with a possible U.S. green light in early 2027, and regulators are assessing it in key markets such as the European Union and China. Beyond COPD, it is being tested in a Phase 2 study in severe asthma and it is in a Phase 3 trial for severe viral lower respiratory tract disease.
Han said that, if cleared, she would begin therapy for patients who have low eosinophil levels, but added there is still no head-to-head evidence to show how it stacks up against existing biologics for patients with high eosinophils. She wants deeper subgroup analyses to guide whether to use it before or after currently available therapies, and she is watching how the Global Initiative for Chronic Obstructive Lung Disease Science Committee sets future guidance.
Dobber also flagged rising air pollution and wildfire smoke as overlooked triggers of COPD flare-ups. "Not everyone has a smoking history," he remarked, explaining that very small particles - including those from wildfire smoke - can inflame the lungs, which he described as a "very sensitive organ." If the drug delivers on this broad utility story, you are looking at a potential blockbuster entering a big, underpenetrated market. That can ripple into earnings, pipeline confidence, and how investors value large-cap pharma tackling chronic diseases that touch tens of millions of people.
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