FDA starts review of AstraZeneca's COPD candidate
核心洞察
The FDA has begun a priority review of AstraZeneca's IL-33 (搜索)-targeting antibody tozorakimab for chronic obstructive pulmonary disease (搜索), with a decision expected in the first quarter of 2027.
The filing rests mainly on the phase 3 OBERON and TITANIA trials, where a once-monthly 300 mg subcutaneous dose cut moderate and severe exacerbations by 30% and 29% versus placebo.
AstraZeneca used a priority review voucher, and the OBERON and TITANIA results were simultaneously published in the New England Journal of Medicine and presented at the ERS congress.
The FDA has started a priority review of AstraZeneca's IL-33 (搜索)-targeting antibody tozorakimab for chronic obstructive pulmonary disease (搜索) (COPD), setting up a decision in the first quarter of 2027. AstraZeneca is spending a priority review voucher, typically worth $100 million to $200 million on the open market, to move the filing through the agency as quickly as possible.
The submission is based mainly on the phase 3 OBERON and TITANIA trials, in which a once-monthly 300 mg subcutaneous dose of tozorakimab significantly reduced moderate and severe COPD exacerbations. In OBERON the relative reduction versus placebo, on top of standard inhaled care, was 30%, and in TITANIA it was 29%. Among former smokers, reductions were 29% and 34%, respectively. The studies enrolled former and current smokers with a broad range of lung function and inflammatory eosinophil levels, a contrast with the current COPD biologics Dupixent (dupilumab) and Nucala (mepolizumab), which are labelled only for patients with elevated eosinophil counts.
An integrated analysis of OBERON and TITANIA presented at the European Respiratory Society congress in Barcelona also showed a reduction in mucus plug score, a biomarker linked to worse COPD outcomes; AstraZeneca said tozorakimab is the first biologic to reduce mucus plugging in a broad COPD population. The results were published in the New England Journal of Medicine. AstraZeneca has previously reported topline data from a third study, MIRANDA, testing a two-weekly dose in patients with ongoing moderate-to-severe exacerbations on inhaled standard of care. Tozorakimab is also under review in the EU and China and is in phase 3 in severe viral lower respiratory tract disease and phase 2 in severe asthma (搜索).