AstraZeneca’s Tozorakimab Shows ~30% Reduction in COPD Exacerbations in Late-Stage Trials

AstraZeneca reported that the experimental monoclonal antibody tozorakimab reduced moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations. In former smokers, moderate exacerbations fell 29% and severe episodes 34% versus placebo. In the combined cohort of current and former smokers, reductions were 30% for moderate and 29% for severe exacerbations. Sub-analyses showed efficacy across eosinophil levels: 23% reduction for < 150 cells/µL, 34% for >= 150, and 43% for >= 300. The only drug-related adverse reaction identified was injection-site irritation.

AstraZeneca reports tozorakimab COPD trial results

COPD is a progressive lung disease that narrows airways, causing persistent breathlessness and frequent flare-ups. In the United States an estimated 16 million to 26 million people live with COPD, making it the fifth-leading cause of death nationally. Existing biologic therapies such as Dupixent and Nucala are approved only for patients with high eosinophil counts, leaving many COPD patients without targeted options.

AstraZeneca drug cuts COPD flare-ups in full data

• 27 March 2026 – AstraZeneca announced that tozorakimab met its primary endpoint in both OBERON and TITANIA.

AstraZeneca reports tozorakimab COPD trial results

• 8 September 2026 – The FDA accepted the Biologics License Application for tozorakimab 300 mg under Priority Review.

AstraZeneca reports tozorakimab COPD trial results

• 9 September 2026 – Full trial data confirmed the ~30% reduction in exacerbations and a reduction in mucus-plug scores.

AstraZeneca’s New COPD Drug Cuts Lung Attacks by Around 30% in Late-Stage Trials

• First quarter 2027 – Anticipated FDA decision date.

Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials

• Patients enrolled: 2,306 adults with symptomatic COPD and a recent exacerbation history.

AstraZeneca Tozorakimab BLA Accepted for FDA Priority Review in COPD

• Dosing regimen: 300 mg every four weeks, added to standard inhaled therapy for 52 weeks.

AstraZeneca Tozorakimab BLA Accepted for FDA Priority Review in COPD

• Efficacy:

AstraZeneca Tozorakimab BLA Accepted for FDA Priority Review in COPD

• Former smokers: 29% reduction in moderate, 34% in severe exacerbations.

AstraZeneca Tozorakimab BLA Accepted for FDA Priority Review in COPD

• Overall cohort: 30% reduction in moderate, 29% in severe exacerbations.

AstraZeneca Tozorakimab BLA Accepted for FDA Priority Review in COPD

• Eosinophil subgroups: 23% (< 150), 34% (>= 150), 43% (>= 300).

AstraZeneca reports tozorakimab COPD trial results

• Safety: Injection-site reaction was the sole identified adverse event; overall tolerability was described as favourable.

AstraZeneca Tozorakimab BLA Accepted for FDA Priority Review in COPD

• Mucus plugging: Integrated analysis showed a statistically significant decrease in mucus-plug scores, an outcome linked to poorer COPD prognosis.

Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials

AstraZeneca highlighted the breadth of the trial population and the novel mechanism of targeting both reduced and oxidised forms of interleukin-33 (IL-33). The FDA’s acceptance of the application under Priority Review signals regulatory confidence, building on Fast Track Designation granted in December 2024.

AstraZeneca Tozorakimab BLA Accepted for FDA Priority Review in COPD

AstraZeneca raised its peak annual sales forecast for tozorakimab to over $5 billion, projecting it could help the company reach its $80 billion revenue target by 2030. The projected market reflects the large, under-served COPD population—including patients with low eosinophil counts who currently lack biologic options.

AstraZeneca reports tozorakimab COPD trial results

• Regulatory: FDA decision expected in the first quarter of 2027; reviews are ongoing in the EU and China.

Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials

• Clinical development: AstraZeneca is pursuing a Phase II trial in severe asthma and a Phase III trial in severe viral lower-respiratory tract disease.

Tozorakimab demonstrated statistically significant and highly clinically meaningful reduction in COPD exacerbations in OBERON and TITANIA Phase III trials

• “We truly believe that a large population of COPD patients can benefit from this new medicine,” — Ruud Dobber, president of AstraZeneca's biopharmaceuticals business unit

CNBC

• “AstraZeneca has clinically validated the novel approach of targeting the signalling of the two forms of IL-33 to both decrease inflammation and disrupt the cycle of mucus dysfunction,” — Sharon Barr, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca

AstraZeneca Tozorakimab BLA Accepted for FDA Priority Review in COPD