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GSK's Exdensur Approved: First Biologic for Severe Asthma

12/17/2025

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Summary

Story summary

GSK Plc received U.S. FDA approval for Exdensur (depemokimab) as an add-on maintenance treatment for severe asthma in patients aged 12 and older.
The FDA-approved regimen makes Exdensur the first biologic to require dosing only twice per year.
The FDA declined its use for chronic rhinosinusitis with nasal polyps.
GSK aims for Exdensur to generate up to £3 billion ($4 billion) annually to offset patent expiries and U.S. tariffs.

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Story summary

GSK Plc received U.S. FDA approval for Exdensur (depemokimab) as an add-on maintenance treatment for severe asthma in patients aged 12 and older.
The FDA-approved regimen makes Exdensur the first biologic to require dosing only twice per year.
The FDA declined its use for chronic rhinosinusitis with nasal polyps.
GSK aims for Exdensur to generate up to £3 billion ($4 billion) annually to offset patent expiries and U.S. tariffs.