AstraZeneca announced full results from two late-stage clinical trials demonstrating that its experimental drug tozorakimab significantly reduced moderate and severe flare-ups in patients with chronic obstructive pulmonary disease (COPD). The biologic medicine, administered via injection once every four weeks, showed efficacy in both former and current smokers, reinforcing its potential as a breakthrough treatment for the progressive lung condition.
Key developments:
- Trial outcomes: The drug reduced moderate and severe COPD flare-ups by 29% to 34% in former smokers and 29% to 30% across a broader population of current and former smokers, compared to a placebo. These results were presented at the European Respiratory Society Congress and are set to be published in a peer-reviewed journal.
- Regulatory pathway: The U.S. Food and Drug Administration (FDA) has accepted tozorakimab for priority review, with a decision expected in the first quarter of 2027. The drug is under evaluation as an add-on maintenance therapy for adults with COPD.
AstraZeneca’s leadership expressed optimism about the drug’s commercial potential. Ruud Dobber, president of the company’s biopharmaceuticals business unit, stated, “We truly believe that a large population of COPD patients can benefit from this new medicine.” CEO Pascal Soriot added that the unmet need in COPD treatment is substantial, noting that only about 10% of eligible patients currently receive biologic therapies. The company has raised its peak annual sales forecast for tozorakimab to more than $5 billion, contributing to its broader revenue target of $80 billion by 2030.
Tozorakimab targets interleukin-33, a protein released by damaged cells that triggers inflammation in COPD and other respiratory conditions. The drug was well-tolerated in trials, with side effects limited to mild injection-site reactions. AstraZeneca is also investigating its potential use in asthma and lower respiratory tract diseases.
COPD, which blocks airflow and makes breathing difficult, affects an estimated 16 million to 26 million Americans and is the fifth-leading cause of death in the U.S., according to AstraZeneca. Current standard care relies on inhaled medications, but biologics like tozorakimab represent a new class of treatments aimed at reducing exacerbations and improving patient outcomes.