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Reported Earlier, FDA Approves Exdensur As The First Ultra-Long-Acting Biologic For Severe Asthma With Eosinophilic Phenotype

Benzinga·12/17/2025 06:28:34
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  • Exdensur is the first and only ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype
  • Approval based on SWIFT trials showing significantly lower rate of annualized asthma exacerbations in patients receiving depemokimab versus placebo
  • SWIFT data included reduction in exacerbations requiring hospitalization and/or emergency department visits with depemokimab
  • An estimated 2 million Americans live with severe asthma and 50% continue to experience frequent exacerbations and hospitalizations requiring novel solutions