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Tozorakimab, an anti-IL-33 monoclonal antibody, significantly cut moderate-to-severe COPD exacerbation rates in two large phase 3 trials (OBERON and TITANIA), making it the first biologic to show broad efficacy regardless of blood eosinophil count or smoking status. Published in the NEJM, the results have AstraZeneca eyeing an FDA approval decision in early 2027.
A new treatment option for COPD patients who keep exacerbating despite standard inhaled therapy is showing real promise. Tozorakimab, an anti-IL-33 monoclonal antibody from AstraZeneca, significantly reduced the annualized rate of moderate-to-severe exacerbations in two replicate phase 3 trials — OBERON and TITANIA — published in The New England Journal of Medicine and presented at the European Respiratory Society International Congress.
What sets tozorakimab apart is its breadth of effect. Unlike previous biologics in this space, it demonstrated consistent benefit across all blood eosinophil count thresholds — including patients with counts below 150 cells/μL, a group historically harder to treat — and across both former and current smokers. The safety profile was comparable to placebo, with injection site reactions being the only notably higher adverse event.
Why it matters: COPD affects millions worldwide, and many patients continue to exacerbate despite maximal inhaled therapy. Tozorakimab's ability to benefit a broad, unselected population — not just high-eosinophil patients — could meaningfully expand who qualifies for biologic treatment. With FDA priority review underway and a PDUFA date expected in Q1 2027, this therapy may soon offer clinicians a powerful new tool.
