AstraZeneca Secures FDA Priority Review for COPD Drug Tozorakimab After Successful Late-Stage Trials
AstraZeneca has received FDA priority review for tozorakimab, a biologic for chronic obstructive pulmonary disease (COPD), following positive results from the Oberon and Titania trials. The drug, administered every four weeks, reduced moderate and severe exacerbations by 29% to 34% in former smokers and 29% to 30% in the broader population. Unlike existing biologics limited by eosinophil counts, tozorakimab showed efficacy across all patient subgroups, including those with low eosinophils. AstraZeneca raised its sales forecast to over $5 billion, citing the drug's broad applicability and the lack of competing IL-33 inhibitors. The company attributes success to blocking both ST2 and EGFR pathways, addressing inflammation and mucus production. U.S. approval is expected in the first quarter of 2027.