GSK’s Exdensur approved in China for severe eosinophilic asthma

Approval

China's NMPA approved Exdensur (depemokimab) as add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 years and older.

Clinical evidence

Approval was based on phase III SWIFT-1 (n=382) and SWIFT-2 (n=380), where depemokimab plus standard of care reduced annualised exacerbation rates by 58% (rate ratio 0.42; AER 0.46 vs 1.11) and 48% (rate ratio 0.52; AER 0.56 vs 1.08) respectively over 52 weeks; Chinese participants in SWIFT-1 (n=58) showed consistent results; full results were presented at ERS 2024 and published in NEJM.

Hospitalisations and pooled analysis

In a secondary endpoint depemokimab showed fewer exacerbations requiring hospital/ED visits (1% and 4% vs placebo 8% and 10%); a pre-specified pooled analysis found a 72% reduction in clinically significant exacerbations requiring hospitalisation/ED (rate ratio 0.28; AER 0.02 vs 0.09; nominal p=0.002).

Safety and dosing

Depemokimab is an ultra‑long‑acting IL‑5 targeting biologic enabling twice‑yearly dosing and was generally well tolerated with similar adverse event rates and severity to placebo across the trials.

Regulatory status and disease burden

NMPA is also reviewing Exdensur for chronic rhinosinusitis with nasal polyps; the drug is approved in the US, Japan, EU and UK; asthma affects an estimated 46 million adults in China, of whom ~6% have severe asthma and ~15% experienced an exacerbation requiring a hospital visit in the prior 12 months.