Tozorakimab’s (interleukin-33 (IL-33) inhibitor) Phase III chronic obstructive pulmonary disease (COPD) results strengthen the case for a new class of biologic treatment that could extend beyond eosinophil-defined patients. Consistent efficacy across OBERON and TITANIA trials, including those with low eosinophil counts, could broaden the addressable COPD population and intensify competition in a market where current biologics remain concentrated among patients with type 2 inflammation, says GlobalData, a leading intelligence and productivity platform.
AstraZeneca presented full results at the 2026 European Respiratory Society (ERS) Congress in Barcelona with simultaneous publication in the New England Journal of Medicine.
Zaid Mahmood, Healthcare Analyst at GlobalData, comments: “With the results of TITANIA and OBERON, tozorakimab challenges the assumption that COPD biologics must be eosinophil-restricted to work, and the consistency across two replicate trials makes this one of the stronger COPD readouts documented in recent years.”
Tozorakimab was able to reduce exacerbation rates in former smokers in both OBERON and TITANIA compared with placebo. The subgroup analysis by blood eosinophil count (BEC) was the more consequential finding: the benefit held in patients with low eosinophil counts, a population where most COPD biologics have historically underperformed, and strengthened progressively as eosinophil levels rose. Safety data showed the drug was well tolerated, with discontinuations due to severe adverse events uncommon and comparable across both trials.
Mahmood adds: “This is the first time a COPD biologic has shown efficacy across the eosinophil spectrum, including below the 150 thresholds, regardless of smoking status, which makes it a key differentiator from the other approved biologics currently in the market.”
The data arrive alongside news that the FDA has accepted tozorakimab’s biologics license application under priority review, with a PDUFA date expected in Q1 2027, while regulatory review is also underway in the EU and China. This puts tozorakimab ahead of rival IL-33 candidates such as Roche’s astegolimab and gives AstraZeneca a strong entry into a COPD biologics market, which is still dominated by Sanofi’s Dupixent (dupilumab), which is restricted to patients with type 2 inflammation (BEC ≥300 cells/µL).
Sanofi’s own IL-33 inhibitor, itepekimab, was discontinued in COPD in 2026 after mixed Phase III results, leaving tozorakimab as the only IL-33 asset with positive Phase III data across the eosinophil spectrum. Sanofi retains countermeasures, however, in its bispecific nanobody lunsekimig, which reported strong Phase IIb asthma results at the same ERS congress, has an ongoing Phase IIb/III clinical trial in COPD.
Mahmood concludes: “By demonstrating benefit across the eosinophil spectrum, tozorakimab is well positioned to become the first biologic approved for a broad COPD population rather than the narrower severe segment served by existing therapies. GlobalData forecasts the COPD market to grow to over $30 billion across the 7MM by 2034, with Dupixent, Nucala, and tozorakimab as the leading drugs.”
