Scottish Medicines Consortium accepts Sanofi’s innovative medicine, Dupixent®▼ (dupilumab), for the treatment of moderate to severe atopic dermatitis
- First biologic drug made available routinely from NHS Scotland for the treatment of moderate to severe atopic dermatitis in adult patients who have had inadequate response to, or are considered unsuitable for treatment with existing systemic immunosuppressants.1
- Atopic dermatitis is the most common type of eczema, affecting approximately 1.5 million adults in the UK.,
- Patients with atopic dermatitis can face significant physical and psychological burdens if the disease is not adequately controlled.
GUILDFORD, UK – 10 SEPTEMBER, 2018 – The Scottish Medicines Consortium (SMC) has accepted Dupixent® (dupilumab) for restricted use within its existing Marketing Authorisation.1 In its advice, the SMC states that dupilumab can be used within the National Health Service (NHS) Scotland for the treatment of adults with moderate to severe atopic dermatitis (also known as atopic eczema) who have had an inadequate response to existing systemic immunosuppressants such as ciclosporin, or in whom such treatment is considered unsuitable.1 In the SMC advice, Dupixent® was considered a therapeutic advancement by the clinical experts consulted.
“This new treatment is a highly significant step forward for people living with more severe atopic eczema in Scotland”, said Andrew Proctor, Chief Executive of the patient charity National Eczema Society. “Atopic eczema can be a cruel, never-ending condition, with constant itching and inflamed painful skin, and the many negative physical and mental health effects have a profound impact on people’s day-to-day life. Dupilumab offers people with a more severe form of atopic eczema a much needed new treatment option in a disease area where therapies have been limited.”
- In the United Kingdom, approximately 1.5 million (3%) adults have atopic dermatitis, the most common form of eczema.3,4
Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme added: “From the start of the dupilumab journey, we have been committed to supporting the physical and emotional well-being of people with atopic dermatitis. Today’s advice from the SMC means this innovative treatment is available to patients in greatest need and marks another important milestone for dupilumab.”
Notes to Editors
About Moderate to Severe Atopic Dermatitis (AD)
Moderate to severe atopic dermatitis is characterised by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting and oozing.6, Itch is one of the most burdensome symptoms for patients and can be debilitating. In addition, people with moderate to severe atopic dermatitis experience impaired quality of life, including disrupted sleep as well as symptoms of anxiety and depression.5
About Dupixent® (dupilumab)
Dupixent® is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, interleukin-4 and interleukin-13 (IL-4 and IL-13), which are believed to be major drivers of the persistent underlying inflammation in atopic dermatitis. Dupixent® was granted a marketing authorisation in the European Union on 27 September 2017.
The medicine is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
The full summary of product characteristics for dupilumab can be accessed at: https://www.medicines.org.uk/emc/product/8553/smpc
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NHS Choices. Atopic Eczema (Atopic Dermatitis). Available at: https://www.nhs.uk/conditions/atopic-eczema/ (Accessed September 2018).
Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66 (suppl 1): 8–16.
Office for National Statistics. 2014 UK mid-year population estimate. Available at: https://www.ons.gov.uk/peoplepopulationandcommunity/populationandmigration/populationprojections/bulletins/nationalpopulationprojections/2015-10-29 (Accessed September 2018).
Simpson et al. Patient burden of moderate to severe atopic dermatitis (AD): Insights from a phase 2b clinical trial of dupilumab in adults. Am Acad Dermatol, pp. 74(3):491-498, 2016.
Sanofi. Data on File. August 2016.
Mount Sinai. Patient Care Atopic Dermatitis. Available at: http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk. (Accessed September 2018).
Simpson et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. NEJM, vol. 375, pp. 2335-2348, 2016. SOLO 1: Available at: https://clinicaltrials.gov/ct2/show?term=solo&cond=Atopic+Dermatitis&rank=3. (Accessed August 2018). SOLO 2: https://clinicaltrials.gov/ct2/show?term=solo&cond=Atopic+Dermatitis&rank=2. (Accessed September 2018).
European Medicines Agency. Dupilumab. Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/004390/WC500236507.pdf (Accessed September 2018).