NICE greenlights Dupixent as add-on therapy for uncontrolled COPD with raised eosinophils in England, marking first targeted biologic for this indication | iPharmaCenter

The UK's National Institute for Health and Care Excellence (NICE) issued final draft guidance on January 26, 2026, recommending Dupixent (dupilumab ; Sanofi/Regeneron) for adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) that remains uncontrolled despite maximal inhaled therapy.

Eligible patients must show elevated blood eosinophils (≥300 cells/μL), indicating type 2 inflammation, and have had ≥1 severe or ≥2 moderate exacerbations in the prior year. Administered via self-injection every two weeks as an add-on to triple inhaled therapy (ICS/LABA/LAMA) or dual therapy if ICS is unsuitable, rollout is expected within 90 days in England pending final guidance.

Approval stems from Phase 3 BOREAS and NOTUS trials involving 1,874 adults aged 40–85 with moderate-to-severe COPD and type 2 inflammation. Both studies met primary endpoints, showing dupilumab significantly reduced annualized moderate/severe exacerbation rates versus placebo.

• Primary endpoint: Annualized moderate/severe exacerbations, 0.79/year for dupilumab vs. 1.16/year placebo.

• Key secondary endpoints: Pre-bronchodilator FEV1 change from baseline, week 12: +147 mL dupilumab vs. +64 mL placebo; week 52: +133 mL vs. +59 m. SGRQ total score at week 52 improved more with dupilumab (LS mean difference -3.4).

Up to 30,000 patients in England could benefit, potentially averting thousands of exacerbations and easing ~130,000 annual COPD-related emergency admissions. Modeling suggests ~3,600 fewer attacks if half of eligibles are treated, yielding £16.5m in NHS savings by cutting steroid use and hospitalizations. An innovative commercial arrangement with Sanofi enables rapid NHS access.

COPD affects ~1.2 million diagnosed UK patients, causing airway obstruction, breathlessness, cough, and exacerbations that accelerate lung decline and raise mortality risk. Type 2 inflammation drives 20–40% of cases, linked to higher exacerbation odds; until now, options were limited to bronchodilators and steroids. Dupilumab, a monoclonal antibody blocking IL-4/IL-13 signaling, addresses this root cause—first such biologic for COPD post-2024 MHRA approval.