Overview

• RESOLUTE was a randomized, double-blind, placebo-controlled Phase III study in moderate to very severe COPD with elevated blood eosinophils (≥300 cells/µL) and frequent prior exacerbations.
• Participants (n=689) received standard ICS/LABA/LAMA therapy plus either placebo or benralizumab 100 mg dosed every four weeks for three doses, then every eight weeks.
• The primary endpoint—annualized rate of moderate or severe exacerbations in those with three or more prior-year events—showed numerical improvement with Fasenra but was not statistically significant.
• The safety and tolerability profile matched the known profile of benralizumab, and AstraZeneca says it will analyze the full dataset and share results with the scientific community.
• Fasenra remains approved for eosinophilic diseases, generating $920 million in H1 2025 sales, and AstraZeneca separately reported a positive late-stage result for Saphnelo in systemic lupus erythematosus.