AstraZeneca COPD drug cuts flare-ups across all patient types in late-stage trials
New CapabilitiesTozorakimab reduced moderate-to-severe exacerbations by up to 34% and worked regardless of eosinophil levels, unlike existing biologics
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Overview
Updated 1 hour agoMillions of COPD patients who don't respond to current biologic treatments may soon have a new option. AstraZeneca's tozorakimab cut moderate-to-severe flare-ups by 29% to 34% in two late-stage trials, and unlike existing biologics, it worked across all blood eosinophil levels.
The drug blocks IL-33, a protein that drives airway inflammation and mucus production. If approved, it would be the first COPD biologic available to patients with low eosinophil counts, expanding treatment to millions who currently have no biologic option.
Why it matters
If approved, tozorakimab would be the first COPD biologic that works regardless of eosinophil levels, giving millions of patients a new option.
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People Involved
Organizations Involved
British-Swedish pharmaceutical company developing tozorakimab, a monoclonal antibody targeting IL-33.
US regulator reviewing tozorakimab for COPD approval, with a PDUFA date expected in Q1 2027.
Academic institution whose researchers co-led the Phase III trials of tozorakimab.
Timeline
December 2024 September 2026
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Results published in NEJM; FDA review underway
Latest PublicationFull results published in the New England Journal of Medicine. BLA under Priority Review with PDUFA date expected Q1 2027.
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Tozorakimab Phase III results presented at ERS 2026
Clinical TrialAstraZeneca presented OBERON and TITANIA results in Barcelona, showing 29-34% reduction in moderate-to-severe COPD flare-ups in former smokers.
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FDA grants Fast Track designation for tozorakimab in COPD
RegulatoryThe FDA granted Fast Track designation for tozorakimab as a COPD treatment, speeding up development and review.
Historical Context
2 moments from history that rhyme with this story — and how they unfolded.
IL-33 inhibitor struggles (2019-2026)
Multiple companies pursued IL-33 inhibitors for respiratory disease with limited success, leading investors and researchers to question whether the target was viable. Roche's astegolimab remains in Phase III.
Several programs stalled or failed to meet endpoints.
IL-33 became seen as a risky target for respiratory biologics.
Tozorakimab's Phase III success suggests its dual-pathway mechanism may overcome the limitations of earlier IL-33 drugs.
Dupixent COPD approval (2024)
Sanofi and Regeneron's dupilumab (Dupixent) became the first biologic approved for COPD, but only for patients with high blood eosinophil counts. The approval followed trials showing reduced exacerbations in that subset.
Dupixent became the standard biologic for eosinophilic COPD.
It established biologics as a COPD treatment but left most patients without a biologic option.
Tozorakimab aims to expand biologic treatment to all COPD patients, including the majority who don't qualify for Dupixent.
