Overview
- The company released full results from two replicate late‑stage trials showing tozorakimab lowered moderate and severe COPD exacerbations by about 29%–34% in former smokers and roughly 29%–30% in the larger enrolled population versus placebo.
- Trials enrolled current and former smokers across all blood eosinophil counts and showed benefit in low‑eosinophil patients, with subgroup reductions reported at 23% for the lowest group, 34% for eosinophils ≥150, and 43% for eosinophils ≥300.
- AstraZeneca reported that tozorakimab was generally well tolerated in the trials, with the main adverse events limited to injection‑site reactions and no new major safety signals disclosed in the released data.
- The FDA has accepted the application for Priority Review and AstraZeneca says it expects U.S. approval in early 2027 while pursuing regulatory reviews in the EU and China and increasing its peak sales forecast for the drug to more than $5 billion.
- Investigators welcomed the results but asked for more detailed subgroup cuts and head‑to‑head comparisons with existing eosinophil‑targeted biologics because clinicians need clear guidance on where to place the drug and many more patients could become eligible if its benefit is confirmed.