GSK plc Secures EU Approval for Exdensur (Depemokimab) in Severe Asthma and CRSwNP

GSK plc Secures EU Approval for Exdensur (Depemokimab) in Severe Asthma and CRSwNP

By, Admin 18 February 2026

GSK announced that the European Commission has approved Exdensur (depemokimab) for:

  • Add-on maintenance treatment of severe asthma with type 2 inflammation in patients aged 12 and older
  • Add-on therapy for severe chronic rhinosinusitis with nasal polyps (CRSwNP) in adults inadequately controlled by systemic corticosteroids and/or surgery

The approval positions Exdensur as the first ultra-long-acting anti-IL-5 biologic offering twice-yearly dosing in these indications.

Mechanistic Differentiation: Ultra-Long-Acting IL-5 Suppression

Depemokimab targets interleukin-5 (IL-5), a key cytokine driving eosinophilic type 2 inflammation.

What differentiates it:

  • High IL-5 binding affinity
  • Extended half-life
  • Sustained suppression of eosinophilic inflammation
  • Dosing every six months (26 weeks)

This contrasts with existing anti-IL-5 biologics that typically require monthly or every-8-week administration. Strategically, dosing frequency is the core competitive lever.

Phase III Evidence Base

SWIFT-1 and SWIFT-2 (Severe Asthma)

Primary endpoint: Annualised exacerbation rate (AER) over 52 weeks.

Results:

  • 58% reduction in SWIFT-1
  • 48% reduction in SWIFT-2
  • Both p < 0.001

Hospitalisation and emergency visit reductions:

  • 72% reduction in pooled analysis (rate ratio 0.28, p=0.002)

These results were published in the New England Journal of Medicine and presented at the European Respiratory Society.

ANCHOR-1 and ANCHOR-2 (CRSwNP)

At 52 weeks:

  • Significant reduction in nasal polyp score
  • Improvement in nasal obstruction severity

All endpoints met statistical significance. Data were presented at the AAAAI/WAO Joint Congress and published in The Lancet.

Market Context: Severe Asthma and CRSwNP

Severe Asthma

  • 42 million people affected in Europe
  • 5–10% classified as severe
  • Many remain uncontrolled despite high-dose ICS and additional controllers

CRSwNP

  • Nearly half of patients remain uncontrolled
  • Surgery and systemic steroids carry recurrence and safety limitations

Biologics targeting type 2 inflammation have already reshaped both markets. However, adherence and injection burden remain practical challenges.

Competitive Landscape

Depemokimab enters a market dominated by:

  • Anti-IL-5 therapies
  • Anti-IL-5 receptor therapies
  • Anti-IL-4/IL-13 pathway agents

Key differentiator: dosing frequency.

If twice-yearly administration maintains efficacy parity with monthly biologics, it could:

  • Improve adherence
  • Reduce healthcare system burden
  • Enhance patient preference
  • Strengthen payer positioning

However, magnitude of effect versus established competitors will determine share capture.

Strategic Pipeline Expansion

Depemokimab is also being evaluated in:

  • OCEAN (EGPA)
  • DESTINY (HES)
  • ENDURA-1/2 and VIGILANT (COPD with type 2 inflammation)

This reflects a lifecycle strategy across eosinophil-driven diseases. If successful in COPD, that would represent a significantly larger commercial expansion.

Global Regulatory Momentum

Exdensur has already received:

  • US approval for severe asthma
  • UK marketing authorisation
  • Japan approval in severe asthma and CRSwNP

EU approval strengthens global positioning and reinforces launch momentum.

Strategic Takeaway

GSK’s EU approval of Exdensur signals:

  • A maturation of ultra-long-acting biologic engineering
  • A competitive move centered on convenience and sustained control
  • Further consolidation of GSK’s leadership in respiratory biologics

The real competitive question is no longer whether IL-5 works — that is established.

The new battleground is:

Can twice-yearly dosing meaningfully redefine standard of care in eosinophilic respiratory disease?

If adherence advantages translate into real-world outcome gains, depemokimab could shift treatment algorithms across asthma and CRSwNP — and potentially beyond.

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