AstraZeneca COPD drug tozorakimab shows positive late-stage trial results

AstraZeneca on Tuesday released full results from two successful late-stage trials on its experimental drug for chronic obstructive pulmonary disease, boosting hopes that it could generate multibillion-dollar sales for the company. 

The biologic medicine, tozorakimab, is under priority review by the Food and Drug Administration, with U.S. approval expected in the first quarter of 2027. The drug, administered once every four weeks, helped reduce flare-ups in a broad range of people with the condition. 

“We truly believe that a large population of COPD patients can benefit from this new medicine,” Ruud Dobber, president of AstraZeneca’s biopharmaceuticals business unit, said in an interview. 

The treatment reduced moderate and severe COPD flare-ups in the primary population of former smokers by 29% and 34%, respectively, compared to a placebo on top of the current inhaled standard of care. The drug, tozorakimab, also reduced moderate and severe flare-ups in a larger overall population of current and former smokers by 30% and 29%, respectively, compared to the placebo group.  

The detailed data reinforces hopes that the product could be a breakthrough treatment for COPD, a progressive lung disease that blocks airflow and makes breathing difficult. An estimated 16 million to 26 million Americans, both diagnosed and undiagnosed, have COPD, and the condition is the fifth-leading cause of death in the U.S., according to AstraZeneca. 

AstraZeneca recently raised its peak annual sales forecast for the drug to more than $5 billion, which could help the company reach its overall $80 billion revenue target by 2030. In an interview with CNBC, CEO Pascal Soriot said the drug has the opportunity to capture a broad group of patients.

“We believe it can be more than 5 billion, simply because the unmet need is huge,” Soriot said. “Patients are underdiagnosed; they need to be better diagnosed, and biologics in this class are totally 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.”

That optimistic outlook for the drug is driven by the fact that it could reach more patients than the currently available biologics for COPD – Dupixent and Nucala – which are limited to those with high levels of white blood cells called eosinophils. 

Regeneron and Sanofi‘s Dupixent is one of the world’s top-selling medications, and GSK’s Nucala joined the COPD market last year. 

“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 investigators of the study.

Dobber added that AstraZeneca’s drug could “really change the treatment paradigm because of its broad utility.”

AstraZeneca’s two trials on tozorakimab included both former and current smokers, and patients across all blood eosinophil…