EU Approves GSK's Twice-Yearly Asthma Drug Exdensur

The European Commission approved GSK's Exdensur (depemokimab) on 21 August 2026 for two indications at once: severe asthma with type 2 inflammation, and chronic rhinosinusitis with nasal polyps (CRSwNP). The approval's headline feature is dosing interval — twice a year, versus the monthly injections of GSK's own established IL-5 inhibitor, Nucala (mepolizumab).

Two indications, one submission

GSK sought and secured a combined label rather than sequencing the two indications separately: add-on maintenance treatment for severe asthma with type 2 inflammation — defined by blood eosinophil count — in patients 12 and older who remain inadequately controlled on high-dose inhaled corticosteroids plus another asthma controller; and add-on therapy alongside intranasal corticosteroids for adults with severe CRSwNP not adequately controlled by systemic corticosteroids, surgery, or both. Both indications target the same interleukin-5 pathway GSK's Nucala has addressed since 2015, but depemokimab's engineered extended half-life is what changes the practical prescribing calculus: a biologic a patient takes twice a year, rather than twelve times, changes adherence math and clinic-visit burden alike.

What the trial data actually showed

The asthma indication rests on the SWIFT-1 and SWIFT-2 Phase 3 trials, which randomized 382 and 380 participants with severe asthma, respectively, to depemokimab or placebo on top of standard of care. The CRSwNP indication rests on the ANCHOR program. GSK reports that pooled SWIFT results showed a 54% reduction in clinically significant exacerbations over 52 weeks — 0.51 exacerbations per patient-year on depemokimab against 1.11 on placebo — and a 72% reduction in the subset of exacerbations severe enough to require hospitalization or an emergency department visit. Each of the four pivotal trials across both indications met its primary or co-primary endpoint, which is what let GSK pursue the joint filing rather than staggering the indications.

A rollout already underway elsewhere

This is not depemokimab's first regulatory decision. The CHMP's positive opinion cleared committee in December 2025, and the European Commission issued its initial marketing authorisation for Exdensur on 12 February 2026; the 21 August action is the Commission formally extending that authorisation to cover the combined asthma/CRSwNP label described above. GSK has separately secured approvals in the UK and Japan, and in the US, where the FDA-approved label currently covers severe asthma only — a narrower scope than the EU's dual indication. For RA teams tracking a multi-market biologic launch, the practical takeaway is that label scope, not just approval timing, now diverges by jurisdiction, and each market's prescribing information should be checked individually rather than assumed to match.