NICE issued final draft guidance recommending dupilumab for eligible COPD patients, positioning it to become the first NHS-recommended biologic for COPD treatment in England & Wales

• The National Institute for Health and Care Excellence (NICE), has published final draft guidance recommending dupilumab as a treatment option for eligible adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils.[1]
• Subject to NICE Final Guidance, the treatment is expected to be available to eligible patients within 60 days in Wales, and 90 days in England. This milestone would mark the first targeted biologic therapy available as a reimbursed option for these patients.
• COPD is a group of lung conditions that cause breathing difficulty due to obstruction or narrowing of the airways.

Reading, 26 January 2026. Sanofi and Regeneron welcome today's announcement of positive final draft guidance from the National Institute for Health and Care Excellence (NICE) recommending Dupixent® (dupilumab) for reimbursement within the NHS as an add-on maintenance therapy for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterised by raised blood eosinophils, on a combination of an inhaled corticosteroid (ICS), a long-acting beta2-agonist (LABA), and a long-acting muscarinic antagonist (LAMA), or on a combination of a LABA and a LAMA if ICS is not appropriate.[1]

COPD is a group of lung conditions that cause breathing difficulty due to obstruction or narrowing of the airways. Symptoms include persistent cough, excessive mucus production, and shortness of breath that may impair the ability to perform routine daily activities, and which may lead to sleep disturbances, anxiety, and depression.[2],[3]  Approximately 1.4 million people in the UK have been diagnosed with COPD, however it is thought as many as 2 million people could be living with the disease undiagnosed.[4],[5]

The COPD positive final draft guidance follows the marketing authorisation for dupilumab that was granted in September 2024, based on data from two Phase 3 clinical studies, BOREAS and NOTUS, both of which were randomised, placebo-controlled, double-blind trials.[6],[7]

Sarah Sleet, Chief Executive at Asthma + Lung UK, said:

“Today’s NICE final draft guidance recommending the use of dupilumab on the NHS for people with uncontrolled chronic obstructive pulmonary disease (COPD), is a major milestone for COPD treatment. 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. COPD is a life-limiting illness that gets more severe over time. It often stops people from performing basic daily tasks as they are left fighting for breath. Only some people with uncontrolled COPD will be eligible for this new treatment so more research is still desperately needed to find further breakthroughs for everyone living with the condition. Alongside major developments like this, there needs to be a drive to get the basics right. Our data indicates that fewer than 1 in 10 people with COPD receive the basic care they need to stay well.[8] Ministers can radically improve COPD care by committing to a respiratory Modern Service Framework to drive up the care standards across the country.” 

Dr Richard Russell, Professor of Respiratory Medicine at King’s College London and Consultant Chest Physician and COPD expert, said:

“The positive final draft guidance of dupilumab by NICE represents a significant clinical breakthrough in how we manage COPD. Our patients and physicians have long awaited targeted treatments that address the underlying inflammation driving the disease. For far too long, patients have been left with limited options beyond inhaled therapies. Ensuring timely and equitable access through clear NHS pathways will be vital.”

Ahmed Moussa, Country Lead, Sanofi UK and Ireland, said:
“We are delighted that today’s final draft guidance proposes eligible COPD patients a new reimbursed option for care, particularly for those with uncontrolled disease. Subject to Final Guidance, dupilumab would become the first targeted biologic reimbursed for COPD in the UK and comes after years of limited innovation in this area. Our next task will be to work together to ensure a positive decision is followed by clear implementation and delivered in a timely way to eligible patients.”

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Notes to editors:

About chronic obstructive pulmonary disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a group of lung conditions that cause breathing difficulty due to obstruction or narrowing of the airways. Symptoms include persistent cough, excessive mucus production, and shortness of breath that may impair the ability to perform routine daily activities, and which may lead to sleep disturbances, anxiety, and depression.[2,3]  COPD is also associated with a significant health and economic burden due to recurrent acute exacerbations that require systemic corticosteroid treatment and/or lead to hospitalisation.[9],[10] Smoking and exposure to noxious particles are key risk factors for COPD, but even individuals who quit smoking can still develop or continue having the disease.[2]

Approximately 1.4 million people in the UK are diagnosed with COPD, however it is thought as many as 2 million people could be living with the disease undiagnosed.4,5 Prevalence of COPD in the most deprived 10% of areas in England is estimated to be double that of the most affluent 10%.[11] Approximately 20 - 40% of patients with COPD show evidence of type 2 inflammation, which is indicated by elevated blood eosinophils and is associated with an increased risk of exacerbations.6 Exacerbations are associated with increased risk of further exacerbations, an accelerated decline in lung-function, and an increased risk of death.[6]

About the dupilumab COPD phase 3 study program

BOREAS and NOTUS were replicate, randomised, phase 3, double-blind, placebo-controlled

studies that evaluated the efficacy and safety of dupilumab in adults who were current or former smokers with moderate-to-severe COPD with evidence of type 2 inflammation, as measured by blood eosinophils ≥300 cells per μL. The studies enrolled 1,874 patients who were aged 40 to 80 years in BOREAS and 40 to 85 years in NOTUS.[6,7]

During the 52-week treatment period, patients in BOREAS and NOTUS received dupilumab or placebo every two weeks added to a maximal standard-of-care inhaled triple therapy of ICS, LABA and LAMA. Double maintenance therapy, which included LABA and LAMA, was allowed if ICS was not appropriate.[6,7]

The primary endpoint for BOREAS and NOTUS evaluated the annualized rate of moderate or severe COPD exacerbations. Moderate exacerbations were defined as those requiring systemic steroids and/or antibiotics. Severe exacerbations were defined as those requiring hospitalisation; requiring more than a day of observation in an emergency department or urgent care facility; or resulting in death. Key secondary endpoints included change from baseline in lung function (assessed by pre-bronchodilator forced expiratory volume in 1 second [FEV1]) at 12 and 52 weeks, change from baseline at 52 weeks in St George's Respiratory Questionnaire (SGRQ) total score compared to placebo, and safety.[6,7]

About dupilumab

Dupilumab is a fully human monoclonal antibody that inhibits the signalling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways. The dupilumab development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation.[6,7]

Dupilumab has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in different age populations.

Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation.

About Sanofi

Sanofi is an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine. We work to turn the impossible into the possible, providing life-changing treatment options and life-saving vaccine protection to millions of people worldwide – while placing sustainability and social responsibility at the heart of what we do.

About Regeneron

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops, and commercialises life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn

MAT-XU-2505064 v1.0 | January 2026

References

[1] NICE (2026). Dupilumab for maintenance treatment of uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11246/documents. (Accessed January 2026).

[2] World Health Organization (2024). Chronic obstructive pulmonary disease (COPD). Available at: https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd) (Accessed January 2026).

[3] Australian Institute of Health and Welfare (2024). Chronic obstructive pulmonary disease (COPD). Available at: https://www.aihw.gov.au/reports/chronic-respiratory-conditions/copd (Accessed January 2026).

[4] NICE (2025). Chronic obstructive pulmonary disease: How common is it? Available at: https://cks.nice.org.uk/topics/chronic-obstructive-pulmonary-disease/background-information/prevalence-incidence/ (Accessed January 2026).

[5] Asthma and Lung UK (2022). COPD in the UK: Delayed diagnosis and unequal care. Executive summary and recommendations. Available at: https://www.asthmaandlung.org.uk/conditions/copd-chronic-obstructive-pulmonary-disease/world-copd-day/delayed-diagnosis-unequal-care (Accessed January 2026)

[6] Bhatt, S. et al. (2023). Dupilumab for COPD with Type 2 Inflammation Indicated by Eosinophil Counts. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2303951 (Accessed January 2026).

[7] Bhatt, S. et al. (2024). Dupilumab for COPD with Blood Eosinophil Evidence of Type 2 Inflammation. Available at: https://www.nejm.org/doi/10.1056/NEJMoa2401304 (Accessed January 2026).

[8] Asthma + Lung UK. Life with a Lung Condition 2025 Basic care briefing. Available at: https://www.asthmaandlung.org.uk/life-lung-condition-2025-basic-care-briefing-december-2025. (Accessed January 2026). 

[9] Safiri, S. et al. (2022). Burden of chronic obstructive pulmonary disease and its attributable risk factors in 204 countries and territories, 1990-2019: results from the Global Burden of Disease Study 2019. Available at: https://www.bmj.com/content/378/bmj-2021-069679 (Accessed January 2026).

[10] Li, J. et al. (2024). Association of blood eosinophils with corticosteroid treatment failure stratified by smoking status among inpatients with AECOPD. Available at: https://bmjopenrespres.bmj.com/content/11/1/e001634 (Accessed January 2026).

[11] Kulakiewicz, A. et al. (2021). Support for people with chronic obstructive pulmonary disease. Available at: https://commonslibrary.parliament.uk/research-briefings/cdp-2021-0188/ (Accessed January 2026).