AstraZeneca on Tuesday published full results from two successful late-stage trials of its experimental chronic obstructive pulmonary disease drug tozorakimab, signaling the medicine could become a multibillion-dollar seller and reach patients who cannot use current biologic therapies.
The biologic, administered once every four weeks, reduced moderate and severe COPD flare-ups in the primary population of former smokers by 29% and 34%, respectively, compared with placebo when added to standard inhaled care, according to data released by the company. In a larger overall population that included both current and former smokers, the drug cut moderate and severe flare-ups by 30% and 29%, respectively, versus placebo.
AstraZeneca said the detailed results reinforce hopes that tozorakimab could be a breakthrough treatment for COPD, a progressive lung disease that blocks airflow and makes breathing difficult. The company estimates that 16 million to 26 million Americans have the condition, and it is the fifth-leading cause of death in the U.S.
The drug is under priority review by the Food and Drug Administration, with U.S. approval expected in the first quarter of 2027. AstraZeneca recently raised its peak annual sales forecast for tozorakimab to more than $5 billion, which could help the company reach its broader $80 billion revenue target by 2030.
CEO Pascal Soriot told CNBC that the drug has the potential to exceed that forecast. “We believe it can be more than 5 billion, simply because the unmet need is huge,” he said, noting that patients are often underdiagnosed and that biologics remain underused. “Maybe 10% of patients receive a biologic. Asthma is 30 to 40% depending on the country. So you can imagine the growth potential is very, very large.”
Broad patient reach is key
The optimism stems largely from tozorakimab’s ability to help patients who are not candidates for existing COPD biologics. Regeneron and Sanofi’s Dupixent and GSK’s Nucala are limited to patients with elevated levels of white blood cells called eosinophils. AstraZeneca’s trials included patients across all eosinophil counts and all stages of lung function severity.
“There’s still a huge number of patients who are not candidates for biologics with the current two approved drugs,” said Dr. Meilan Han, chief of the division of pulmonary and critical care at the University of Michigan Health and one of the study investigators.
For patients with a blood eosinophil count below 150 — a group with no available biologic COPD treatment — the drug reduced moderate and severe flare-ups by 23%, according to an analysis. In those with counts at or above 150, the reduction was 34%, and in patients at or above 300, it was 43%.
Ruud Dobber, president of AstraZeneca’s biopharmaceuticals business unit, said the drug could “really change the treatment paradigm because of its broad utility.”
A different mechanism
Tozorakimab works by blocking the protein IL-33, which drives inflammation and mucus production. Previous attempts by other companies to target IL-33 met with limited success, leading some investors to doubt the approach. Soriot acknowledged on the company’s second-quarter earnings call that “tozorakimab is a product nobody thought would work,” noting that consensus forecasts had nearly zero sales before the trial results emerged.
AstraZeneca says its drug differs from earlier IL-33 candidates by inhibiting two distinct pathways linked to the protein, potentially addressing not just inflammation but also mucus production and airway damage.
Questions remain for doctors
Han said she would likely start patients with low eosinophil counts on tozorakimab once it is available. But she noted that for patients with high eosinophil levels, doctors will still be weighing whether to use the drug before or after existing biologics, since no head-to-head studies have compared them.
“I’m very excited about the data, but I am pushing them that I would like to see additional subgroup cuts of the data to understand how my patients might most benefit,” she said, adding that it remains an open question how providers and the GOLD committee — which issues international COPD guidelines — will position the treatment.
The drug is under regulatory review in major markets including the EU and China and is also being studied in a Phase 2 trial for severe asthma and a Phase 3 trial for severe viral lower respiratory tract disease.
Dobber said he believes tozorakimab “can become one of the largest products in history in respiratory in general.” He also highlighted growing concerns about air pollution and wildfire smoke as contributors to lung damage, noting that “not everyone has a smoking history.” He said he hopes the attention around the new data raises awareness of COPD as a serious disease and prompts broader efforts to reduce environmental triggers.
Source: www.cnbc.com — https://www.cnbc.com/2026/09/08/astrazeneca-copd-drug-tozorakimab-shows-positive-late-stage-trial-results.html
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