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Sanofi Announces Licensing of Dupixent® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis in the European Union

First and only targeted biologic in the European Union to receive marketing authorisation for use in atopic dermatitis

 

Guildford, UK – 28 September, 2017 – Sanofi and its specialty care global business unit, Sanofi Genzyme, today announced that the European Commission (EC) has granted marketing authorisation for Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis (AD) in adults who are candidates for systemic therapy.1 The decision from the EC follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on 21 July, 2017.

Today’s decision is an important step forward for people with moderate-to-severe atopic dermatitis who have had limited treatment options for this systemic, inflammatory,life-long disease,” said Dr Anthony Bewley, Consultant Dermatolgist at Whipps Cross University Hospital and the Royal London Hospital. “Dupilumab is able to target the root cause of the condition, bringing relief to the aggravating and physical symptoms of atopic dermatitis as well as those difficult symptoms that you can’t see and yet have a negative impact on quality of life, like anxiety, depression and sleep. For dermatologists, this will be a much-welcomed new therapy to offer eligible patients.”

Dupilumab is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD, and certain other allergic or atopic diseases.1,2 Dupilumab will come in a pre-filled syringe and can be self-administered by a patient as a subcutaneous injection every other week after an initial loading dose. Dupilumab can be used with or without topical corticosteroids.1

AD (also known as atopic eczema) is the most common form of eczema.3 In the United Kingdom, approximately 1.5 million (3%) adults have atopic dermatitis.4,5 Within the general UK population, it is estimated that there are 14 adults per 100,000 with moderate AD and 6 adults per 100,000 with severe AD who may be eligible for treatment with dupilumab6 Moderate-to-severe AD is characterised by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.7,8 Itch is one of the most burdensome symptoms for patients and can be debilitating.7 In addition, people with moderate-to-severe AD experience impaired quality of life, including disrupted sleep, and increased anxiety and depression symptoms along with their disease.7

“The European Commission’s decision is a significant  milestone for patients whose lives have been severely affected by atopic dermatitis and demonstrates our commitment to bringing innovative new therapies for diseases with high unmet medical needs,” commented Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme. “We are already working with the authorities in the UK with the goal of making dupilumab available on the NHS as quickly as possible for those who need it.”

About Dupilumab Trials

LIBERTY AD Clinical Programme and Results2,9,10,11

The licensing of dupilumab was based on studies from the global LIBERTY AD clinical trial programme, which included nearly 3,000 patients. The studies examined the use of dupilumab either alone (LIBERTY AD: SOLO 1, SOLO 2 and SOLO-CONTINUE) or with topical corticosteroids (LIBERTY AD: CHRONOS and CAFÉ) in moderate-to-severe AD patients who were inadequately controlled with topical prescription therapies or immunosuppresants such as ciclosporin, or for whom those therapies were not advisable. In all these studies, dupilumab alone or with topical corticosteroids met the primary and key secondary endpoints. The most common adverse events that occurred at a higher rate than placebo in the dupilumab group (> one percent) included injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips.

About Sanofi  

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.


1 Sanofi. Data on File. September 2017.

2 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 September 2017).

SOLO 2: https://clinicaltrials.gov/ct2/show?term=solo&cond=Atopic+Dermatitis&rank=2. (Accessed September 2017).

3 NHS Choices. Atopic Eczema (Atopic Dermatitis). Available at: http://www.nhs.uk/conditions/Eczema-(atopic)/Pages/Introduction.aspx (Accessed: September 2017).

4 Nutten S. Atopic Dermatitis: Global Epidemiology and Risk Factors. Ann Nutr Metab 2015;66 (suppl 1): 8–16.

5 Office for National Statistics. 2014 UK mid-year population estimate. Available at: http://www.ons.gov.uk/generator?uri=/peoplepopulationandcommunity/populationandmigration/populationestimates/articles/overviewoftheukpopulation/february2016/ff1144ea&format=xls (Accessed: September 2017).

6 Sanofi. Data on File. August 2016.

7 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.

8 Mount Sinai. Patient Care Atopic Dermatitis. Available at: http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk. Accessed July 2017.

9 SOLO CONTINUE: Available at: https://clinicaltrials.gov/ct2/show/NCT02395133?term=solo&cond=Atopic+Dermatitis&rank=1.   (Accessed September 2017).

10 Blauvelt. A., Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. The Lancet, vol. 389, pp. 2287-2303, 2017.

CHRONOS: Available at: https://clinicaltrials.gov/ct2/show/NCT02260986. (Accessed September 2017).

11 CAFÉ: Available at: https://clinicaltrials.gov/ct2/show/NCT02755649?term=dupilumab&cond=atopic+dermatitis&spons=sanofi&draw=1&rank=7. (Accessed September 2017).

Date of preparation: September 2017: Job bag number: SAGB.DUP.17.09.1158

Updated: September 28, 2017

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