LONDON, January 26, 2026 — A new injection therapy is offering a potential breakthrough for individuals battling severe chronic obstructive pulmonary disease (COPD), as the National Institute for Health and Care Excellence (NICE) has recommended its use on the National Health Service (NHS) in England and Wales. The decision, announced in final draft guidance, could significantly improve the quality of life for a subset of COPD patients.
A New Option for Uncontrolled COPD
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The recommendation centers on dupilumab, a monoclonal antibody, for adults whose COPD remains uncontrolled despite standard treatments and who exhibit elevated levels of blood eosinophils.
- Dupilumab is intended as an add-on treatment for those experiencing frequent COPD exacerbations.
- Patients must be on existing triple or double therapy to be eligible.
- The drug targets type 2 inflammation, present in 30–40% of COPD cases.
- Clinical trials showed a reduction in exacerbation rates compared to placebo.
For years, COPD treatment has remained largely stagnant. This recommendation marks the first biologic therapy poised for availability on the NHS for those with uncontrolled COPD and high eosinophil counts, offering a targeted approach where previously there was little innovation.
Understanding the Eligibility Criteria
NICE defines “uncontrolled COPD” as experiencing one or more severe exacerbations, or two or more moderate exacerbations, within the past 12 months. To qualify for dupilumab, patients must already be receiving either triple therapy – an inhaled corticosteroid, a long-acting beta-2 agonist (LABA), and a long-acting muscarinic antagonist (LAMA) – or double therapy (LABA and LAMA) if inhaled corticosteroids aren’t suitable.
Dupilumab is administered via pre-filled pens, allowing for self-administration every two weeks. The medication works by suppressing inflammation through the inhibition of the interleukin-4 and interleukin-13 signaling pathways.
The Medicines and Healthcare Regulatory Agency initially approved dupilumab in 2023, paving the way for this latest NICE recommendation.
Expert Reactions to the NICE Guidance
Sarah Sleet, chief executive of Asthma + Lung UK, hailed the decision as “a major milestone for COPD treatment.” She stated, “Subject to final guidance, this would become the first biologic therapy available on the NHS for people with uncontrolled COPD, who have high levels of a type of blood cell called an eosinophil.” Sleet also emphasized the need for improved basic COPD care, noting that fewer than one in ten patients currently receive the essential support they require.
Darush Attar-Zadeh, honorary clinical fellow respiratory pharmacist at North West London Integrated Care Board, welcomed the NICE approval, drawing parallels to dupilumab’s success in treating severe asthma since 2021. He stressed the importance of timely and equitable access to the treatment, alongside adequate training and support for healthcare professionals.
Clinical Trial Results Demonstrate Efficacy
According to accompanying documents, clinical trials revealed that patients receiving dupilumab experienced an annual rate of 0.79 moderate or severe exacerbations (95% confidence interval [CI] 0.69 to 0.92), compared to a rate of 1.16 (95% CI 1.01 to 1.33) in the placebo group.
NICE estimates that approximately 30,000 people in England are affected by COPD, with 30–40% of these individuals exhibiting raised eosinophil levels.
The NICE technology appraisal committee acknowledged that COPD disproportionately impacts certain demographics – men, individuals over 40, and those from lower socioeconomic backgrounds. Importantly, the committee recognized that individuals from lower socioeconomic groups would likely benefit significantly from dupilumab, potentially reducing health inequalities.
Ahmed Moussa, country lead at Sanofi UK and Ireland, expressed delight at the draft guidance, stating that dupilumab would represent the first targeted biologic reimbursed for COPD in the UK. He emphasized the commitment to ensuring swift and effective implementation of the treatment for eligible patients.
