AstraZeneca’s COPD drug posts strong Phase 3 results, boosting blockbuster hopes

AstraZeneca ↘ 1.63% on Tuesday released full results from two late-stage trials showing its experimental drug tozorakimab reduced dangerous flare-ups in a broad population of patients with chronic obstructive pulmonary disease, reinforcing the company's projection of more than $5 billion in peak annual sales for the treatment.cnbc+1

The data, presented at the European Respiratory Society Congress in Barcelona and simultaneously published in the New England Journal of Medicine, showed tozorakimab reduced moderate and severe COPD exacerbations by 29% and 34% in the two trials among former smokers, and by roughly 30% in the overall population of current and former smokers, compared to placebo on top of standard inhaled therapy.astrazeneca+1

A Biologic With Broader Reach

What distinguishes tozorakimab from the two currently approved COPD biologics — Regeneron ↘ 2.10% and Sanofi's ↘ 2.45% Dupixent and GSK's ↘ 2.71% Nucala — is its efficacy across all blood eosinophil levels. Existing biologics are limited to patients with elevated eosinophil counts. In a pooled analysis, tozorakimab reduced exacerbations by 23% even in patients with eosinophils below 150, a group for which no biologic treatment currently exists, while patients at or above 300 saw a 43% reduction.astrazeneca+1

"We truly believe that a large population of COPD patients can benefit from this new medicine," Ruud Dobber, president of AstraZeneca's biopharmaceuticals unit, told CNBC.cnbc

The drug works by blocking interleukin-33, a protein that drives both inflammation and mucus production. Previous attempts by other companies to target IL-33 largely failed, but AstraZeneca says tozorakimab inhibits two distinct IL-33 pathways, which may explain its broader efficacy.astrazeneca+1

Road to Market

The FDA has accepted tozorakimab's Biologics License Application under Priority Review, with U.S. approval anticipated in the first quarter of 2027. Regulatory reviews are also underway in the EU and China.cnbc+1

CEO Pascal Soriot acknowledged the drug defied expectations. "Tozorakimab is a product nobody thought would work," he said on the company's second-quarter earnings call. "The consensus had almost zero in its forecast, and it actually worked."cnbc

Questions Remain

Dr. Meilan Han, chief of pulmonary and critical care at the University of Michigan Health and a study investigator, said she would likely start low-eosinophil patients on tozorakimab but noted that without head-to-head studies comparing it to existing biologics, questions remain about sequencing treatments for high-eosinophil patients. "I'm very excited about the data, but I am pushing them that I would like to see additional subgroup cuts," she told CNBC.cnbc

COPD is the third-leading cause of death worldwide, and exacerbations account for more than 2,500 emergency department visits per day in the United States alone.astrazeneca