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3d ago

FDA Clears GSK’s Exdensur as First Twice-Yearly Add-On for Severe Eosinophilic Asthma

The long-acting IL-5 antibody targets eosinophilic disease with a dosing schedule GSK says could improve adherence.

GSK has secured approval from the FDA for its twice-yearly severe asthma add-on maintenance therapy, Exdensur (depemokimab). Image credit: voronaman via ShutterStock.com.
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Overview

  • Exdensur (depemokimab) is approved as an add-on maintenance treatment for patients aged 12 and older with severe asthma characterized by an eosinophilic phenotype.
  • The decision rests on Phase III SWIFT-1 and SWIFT-2 results showing 58% and 48% reductions in annualized exacerbations over 52 weeks versus placebo on standard care.
  • Secondary endpoints showed fewer hospital or emergency department visits versus placebo, with a pooled analysis indicating a 72% reduction in clinically significant exacerbations.
  • The therapy received UK MHRA approval on December 15 and holds a positive CHMP opinion, with an EU decision expected in the first quarter of 2026.
  • Exdensur enters a crowded market led by Dupixent and Xolair, as forecasts project 2031 sales of about $935 million for Exdensur versus $4.8 billion for Dupixent, with Xolair facing U.S. biosimilar competition from Omlyclo following patent expiry.