Depemokimab, developed by GSK and marketed as Exdensur, represents a major advancement in treating severe eosinophilic conditions.
This ultra-long-acting IL-5 inhibitor requires only twice-yearly subcutaneous dosing, offering a convenient alternative to more frequent administration biologics. It's an ultra-long-acting IL-5 inhibitor (twice-yearly dosing) showing promise in reducing nasal polyp size and obstruction in CRSwNP.
This ultra-long-acting IL-5 inhibitor requires only twice-yearly subcutaneous dosing, offering a convenient alternative to more frequent administration biologics. It's an ultra-long-acting IL-5 inhibitor (twice-yearly dosing) showing promise in reducing nasal polyp size and obstruction in CRSwNP.
In late 2025, the FDA approved Exdensur as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 and older. This decision stemmed from positive Phase III SWIFT-1 and SWIFT-2 trials, which demonstrated significant reductions in asthma exacerbations.
For chronic rhinosinusitis with nasal polyps (CRSwNP), Phase III ANCHOR-1 and ANCHOR-2 trials showed promising results: depemokimab significantly reduced nasal polyp size (via endoscopic scores) and improved nasal obstruction compared to placebo, with good tolerability. It met key co-primary endpoints, including changes in total endoscopic nasal polyp score at 52 weeks and mean nasal obstruction scores.
Its potential for rhinosinusitis approval will be piggybacking on its asthma clearance.
Its potential for rhinosinusitis approval will be piggybacking on its asthma clearance.
While the FDA approved it for asthma (but not yet for CRSwNP in USA), the EMA's CHMP issued a positive opinion in December 2025 recommending approval for both severe asthma (with type 2 inflammation) and CRSwNP as add-on therapy. The European Commission decision is anticipated in Q1 2026, potentially enabling broader use across these indications in Europe.
This twice-yearly dosing could reduce treatment burden for patients with these chronic, eosinophil-driven diseases, building on asthma clearance to support potential rhinosinusitis expansion.
Four biologics (dupilumab, mepolizumab, omalizumab, tezepelumab) are now approved in the US for CRSwNP, with ongoing real-world data and reviews on long-term management.
This twice-yearly dosing could reduce treatment burden for patients with these chronic, eosinophil-driven diseases, building on asthma clearance to support potential rhinosinusitis expansion.
Four biologics (dupilumab, mepolizumab, omalizumab, tezepelumab) are now approved in the US for CRSwNP, with ongoing real-world data and reviews on long-term management.