NICE issued final draft guidance recommending dupilumab for eligible severe CRSwNP patients, positioning it to become the first NHS-recommended biologic treatment for treating this condition in England and Wales

• The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending dupilumab as an add-on treatment to intranasal corticosteroids for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), provided that: the condition is not adequately controlled by systemic corticosteroids or sinus surgery; they have had at least one sinus surgery; and their SNOT-22 score is at least 50.[i]
• CRSwNP is a long-term inflammatory condition of the nose and sinuses that causes nasal polyps, leading to loss of smell, blocked breathing and facial pressure.

Reading, 2 February 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 Sanofi and Regeneron welcome today’s announcement of positive final draft guidance from the National Institute for Health and Care Excellence (NICE) recommending Dupixent® (dupilumab) for reimbursement within the NHS as an add-on treatment to intranasal corticosteroids for adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), provided that: the condition is not adequately controlled by systemic corticosteroids or sinus surgery; they have had at least one sinus surgery; and their SNOT-22 score is at least 50.[i]

CRSwNP is a long-term inflammatory condition of the nose and sinuses characterised by nasal polyps, which can obstruct the nasal passages and significantly impair breathing. Symptoms may include loss of smell, persistent nasal blockage, facial pressure or pain and sleep disturbance, with a substantial impact on quality of life.[ii]

The CRSwNP recommendation follows the marketing authorisation for dupilumab in this indication, based on data from two Phase 3 clinical studies, SINUS-24 and SINUS-52, both of which were randomised, placebo-controlled, double-blind trials.[ii]

Duncan Boak, Chief Executive, SmellTaste said:

“I’m very pleased that NICE has issued final draft guidance recommending the use of dupilumab to treat eligible people in the UK with the most severe cases of a chronic disease that has a huge impact on their quality of life and is a leading cause of smell loss. There has been a real need for an effective treatment for those people for whom the current gold-standard treatment, sinus surgery, does not provide lasting relief from symptoms because of the continued regrowth of nasal polyps. Dupilumab is already being used to treat severe CRSwNP in over 30 countries and it is great news that NICE is proposing it to treat eligible patients in England and Wales as well. I hope this helps pave the way for greater recognition and further new treatments for the many people living with chronic rhinosinusitis, which affects around 11% of the UK population.”[iii]

Andrew Knill, CEO, Sinus UK commented:

“This is a very important moment for CRSwNP patients in the UK. CRSwNP is a severely debilitating condition that can leave patients in a desperate state and with very poor quality of life. The most effective treatments for severe patients, corticosteroids or surgery, may only offer a few months or even just a few weeks of symptom relief. Once steroids and surgery prove to be ineffective management options, patients have had nowhere else to go except to enter a recurring cycle of more steroids and more surgery and simply hope for a different outcome. Having dupilumab available on the NHS will change this, providing a much-needed alternative for these patients.”

Professor Claire Hopkins, Consultant ENT Surgeon at Guy's and St Thomas' Hospitals, London, said:

“The availability of dupilumab, as the first reimbursed biologic for NHS patients with CRSwNP, would offer an important alternative treatment option for eligible patients. For patients who experience recurrent symptoms requiring multiple interventions, this represents a significant step forward in care. It's been a privilege to be involved in clinical trials and see the potential benefits that treatment can bring. ENT surgery waiting lists remain a significant challenge in the NHS, and a treatment option that may reduce the need for repeat surgeries in appropriate patients would be a welcome addition to the treatment landscape.”

Ahmed Moussa, Country Lead, Sanofi UK and Ireland, said:
“The availability of a new biologic treatment is a significant moment for eligible people living with CRSwNP. It is a chronic condition that can place a significant burden on daily life, affecting people’s sleep, mood, ability to smell and taste and even their hearing, so continued innovation is essential to improving long-term outcomes for patients. This recommendation reflects Sanofi’s long-term commitment to advancing care for people living with severe inflammatory diseases, working with the NHS and the wider health community to ensure eligible patients can access innovative treatments that make a meaningful difference to their lives.”                                                                                             

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Notes to editors:

About chronic rhinosinusitis with nasal polyps (CRSwNP) [ii],[iv],[v],[vi]

CRSwNP is a long-term condition affecting the spaces inside the nose and head (sinuses).

In people with CRSwNP, the sinuses become inflamed, and their lining becomes swollen, forming soft growths inside the nose called nasal polyps. CRSwNP interferes with the way mucus normally drains[vii] and may cause troublesome symptoms, including loss of smell and taste, blocked nose (nasal congestion/obstruction), difficulties breathing, runny nose (rhinorrhoea), facial pain/pressure, fatigue, trouble sleeping, infections, hearing issues and mucus running down the throat (postnasal drip). These symptoms, especially blocked/runny nose and sleep disturbances, have a significant negative impact on the patients by preventing them from carrying out their daily activities as normal.

There has been limited innovation in treatment options for people living with this condition, and, subject to final guidance, this will mark the first new treatment for over a decade available under the NHS. Many patients require surgery to remove the polyps, yet around 50% of those currently awaiting nasal polyp procedures are scheduled for revision surgery due to regrowth. This recurring need for surgical intervention places a significant burden on the NHS, with costs estimated at £66.7 million between 2010-2020.[viii] 

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.[ix]

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-2600129 v3.0 | January 2026     

References

[i] NICE (2026). Dupilumab for treating severe chronic rhinosinusitis with nasal polyps. Available at: https://www.nice.org.uk/guidance/gid-ta11630/documents/674

[ii] Fokkens, W. J., et al. (2020). "European Position Paper on Rhinosinusitis and Nasal Polyps 2020." Rhinology 58(Suppl S29): 1-464.

[iii] Clarke, C. et al. 2022. Observational retrospective study calculating health service costs of patients receiving surgery for chronic rhinosinusitis in England, using linked patient-level primary and secondary care electronic data. BMJ Open 12 (2): e055603.

[iv] Orlandi, R. R., et al. (2016). "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis." Int Forum Allergy Rhinol 6 Suppl 1: S22-209.

[v] Orlandi, R. R., et al. (2021). "International consensus statement on allergy and rhinology: rhinosinusitis 2021." Int Forum Allergy Rhinol 11(3): 213-739.

[vi] Fokkens, W. J., et al. (2023). "EPOS/EUFOREA update on indication and evaluation of Biologics in Chronic Rhinosinusitis with Nasal Polyps 2023." Rhinology 61(3): 194-202.

[vii] Fifth Sense. Sinonasal Disorders and Allergies 2024. Available from: https://www.fifthsense.org.uk/sinonasal-disorders-and-allergies/ [Accessed December 2025].

[viii] Hopkins C, Conlon S, Chavda S, Hudson R, Rout R. Investigating the secondary care system burden of CRSwNP in sinus surgery patients with clinically relevant comorbidities using the HES database. Rhinology. 2022;60(4):252-60.

[ix] 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).