AstraZeneca Secures FDA Priority Review for COPD Drug Tozorakimab After Successful Late-Stage Trials

Key points

• AstraZeneca's tozorakimab received FDA priority review after the Oberon and Titania trials showed 29-34% reduction in COPD exacerbations in former smokers.
• The drug demonstrated efficacy across all eosinophil levels, including patients with counts below 150, where current biologics like Dupixent are not approved.
• AstraZeneca raised its peak annual sales forecast for tozorakimab to over $5 billion, up from a previous $3-5 billion range.
• The company attributes the drug's success to its dual mechanism blocking both ST2 and EGFR pathways, unlike competitors that targeted only one.
• U.S. approval is expected in the first quarter of 2027, with regulatory reviews ongoing in the EU and China.

Background

COPD remains a major unmet medical need, affecting 16-26 million Americans and ranking as the fifth-leading cause of death in the U.S. Existing biologic therapies, such as Sanofi and Regeneron's Dupixent and GSK's Nucala, are limited to patients with high eosinophil counts, leaving a significant portion of the patient population without biologic options. AstraZeneca's earlier attempts with IL-33 inhibitors faced setbacks, but the company persisted with tozorakimab, which was designed to address both inflammatory and mucus-related pathways. The drug's success follows a period of failed trials for other IL-33 candidates from Sanofi, Regeneron, and Roche.

How outlets are covering it

Fierce Biotech emphasizes AstraZeneca's internal 'science success story' narrative, highlighting the company's 'courageous decisions' to reinvent its IL-33 approach after earlier failures. The outlet notes that attendees at the European Respiratory Society Congress were so engaged by the data that organizers had to clear the room. CNBC focuses on the commercial potential, with CEO Pascal Soriot stating that the drug could generate more than $5 billion in sales due to the huge unmet need and underdiagnosis of COPD. Endpoints News provides limited detail, primarily noting the presentation at the ERS 2026 Congress. AstraZeneca's own source was inaccessible due to a 403 error. Perspectives differ on the drug's positioning: Fierce Biotech highlights the scientific differentiation, while CNBC emphasizes the market opportunity and broad patient applicability. Dr. Meilan Han, a trial investigator, noted that while she is excited about the data, questions remain about how to integrate tozorakimab with existing biologics for patients with high eosinophil counts, as no head-to-head studies exist.

Why it matters

Tozorakimab could significantly expand the treatment options for COPD, a disease with a high mortality rate and limited biologic therapies. By demonstrating efficacy across all eosinophil levels, the drug could reach a broader patient population than current biologics, potentially reducing exacerbations and improving outcomes. The FDA priority review and potential $5 billion sales opportunity underscore the drug's significance for AstraZeneca's revenue targets and the broader respiratory treatment landscape. The success also validates the IL-33 pathway as a viable target for COPD, after previous setbacks for similar drugs.

What to watch

AstraZeneca expects U.S. approval for tozorakimab in the first quarter of 2027. The drug is also under regulatory review in the EU and China. AstraZeneca is conducting Phase 2 trials for severe asthma and Phase 3 trials for severe viral lower respiratory tract disease. The company is also exploring other mechanisms for COPD treatment, including its antibody drug Tezspire for T2-driven disease. Dr. Meilan Han has requested additional subgroup analyses to help clinicians decide when to use tozorakimab relative to existing biologics. The Global Initiative for Chronic Obstructive Lung Disease Science Committee will need to update guidelines to incorporate the new data.