GSK wins FDA approval for ultra-long-acting asthma drug Exdensur (depemokimab)

The US FDA has approved GSK’s Exdensur (depemokimab-ulaa) as an add‑on maintenance treatment for severe asthma characterised by an eosinophilic phenotype (type 2 inflammation) in adults and adolescents 12 years and older.21

Exdensur is the first and only ultra‑long‑acting biologic for severe asthma with twice‑yearly (every 6 months) dosing, offering just two injections per year.21

The drug is a long‑acting IL‑5 inhibitor monoclonal antibody designed to reduce type 2 airway inflammation in severe eosinophilic asthma.31

FDA approval was based on the phase 3 SWIFT‑1 and SWIFT‑2 trials, which showed large reductions in annual severe asthma exacerbations, including those requiring emergency department visits or hospitalisations.12

In clinical data, depemokimab achieved around a 72% reduction in severe exacerbations requiring hospitalisation or ED visits and sustained suppression of blood eosinophils, a key marker of type 2 inflammation.1

GSK highlights that current asthma biologics are typically dosed every 2–4 weeks, so a twice‑yearly option may improve treatment adherence and reduce burden on patients and healthcare systems.12

An estimated 2 million Americans live with severe asthma, and about 50% continue to experience frequent exacerbations and hospitalisations despite existing treatments, underscoring the need for new options like Exdensur.2

The US approval, alongside UK authorisation, positions Exdensur as a new long‑acting standard of care candidate for eligible patients with severe eosinophilic asthma.34

Sources:

1. https://www.patientcareonline.com/view/fda-approves-gsk-s-depimokimab-for-severe-asthma-with-th2-inflammation-first-ultra-long-acting-biologic

2. https://www.gsk.com/media/5aubxrcf/sea-exdensur-depemokimab-approved-by-us-fda.pdf

3. https://pharmaphorum.com/news/uk-us-approve-gsks-twice-yearly-asthma-drug

4. https://global.morningstar.com/en-gb/news/alliance-news/1765965057044339800/gsk-secures-us-fda-approval-for-innovative-severe-asthma-treatment