Exdensur (depemokimab) approved by US FDA for the treatment of severe asthma

GSK

16 December 2025 - Approval based on SWIFT trials showing significantly lower rate of annualised asthma exacerbations in patients receiving depemokimab versus placebo.

GSK today announced that the US FDA has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterised by an eosinophilic phenotype in adult and paediatric patients aged 12 years and older.

Read GSK press release

Michael Wonder

Posted by:

Michael Wonder

Posted in:

Outcome , Medicine , US , Registration