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Sanofi Receives CHMP Positive Opinion for Dupixent® (dupilumab) to Treat Adult Patients with Moderate-to-Severe Atopic Dermatitis

First investigational targeted biologic in the European Union to receive positive CHMP opinion for atopic dermatitis

 

Guildford, UK – 21 July, 2017 – Sanofi and its specialty care global business unit, Sanofi Genzyme, today announced thatthe European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorisation of Dupixent® (dupilumab), recommending its license for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.1 Dupilumab is the first investigational targeted biologic in the European Union to receive positive CHMP opinion for atopic dermatitis.

People with moderate-to-severe atopic dermatitis live with a life-long condition that can have intolerable symptoms impacting all aspects of their lives,” said Dr. Mahreen Ameen, consultant dermatologist, Royal Free London NHS Foundation Trust. “To date, doctors have had very few options to help treat patients with this level of uncontrolled disease. If licensed, dupilumab will be a much welcomed new treatment option.”

“Atopic dermatitis is a condition that can have a detrimental impact on a person’s quality of life, causing physical discomfort and often, emotional distress,” added Peter Kuiper, General Manager UK & Ireland at Sanofi Genzyme. “Today’s CHMP positive recommendation for dupilumab marks an important step forward in bringing this innovative treatment option to those patients at greatest need.

Atopic dermatitis (also known as atopic eczema) is the most common form of eczema.2 In the United Kingdom, approximately 1.5 million (3%) adults have atopic dermatitis.3,4Within the general UK population, it is estimated that there are 14 adults per 100,000 with moderate atopic dermatitis and 6 adults per 100,000 with severe atopic dermatitis who may be eligible for treatment with dupilumab.5Moderate-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 a high level of disrupted sleep, and increased anxiety and depression symptoms due to their disease.7

The European Commission (EC) is expected to adopt a final decision on the Marketing Authorization Application (MAA) for dupilumab in the European Union in the coming months. The CHMP opinion is based on studies from the global LIBERTY atopic dermatitis clinical trial programme, including SOLO 1, SOLO 2, SOLO-CONTINUE, CHRONOS and CAFÉ.8,9,10,11 These studies incorporate data from nearly 3,000 adult patients with moderate-to-severe atopic dermatitis not adequately controlled with topical prescription therapies, or an immunosuppressant such as cyclosporine, or when those therapies were not advisable.  In clinical trials, the most common side effects were injection site reactions, viral infections such as herpes affecting the mouth, dry eye and similar symptoms affecting the eye.

Today’s announcement follows a decision earlier this year by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), who granted dupilumab a positive scientific opinion through the Early Access to Medicines Scheme (EAMS).12

About dupilumab

Dupilumab is an investigational fully human monoclonal antibody. It is a targeted immunotherapy that inhibits signalling of IL-4 and IL-13, two key cytokines required for the Type2 (including Th2) immune response, which is believed to be a fundamental driver of inflammation associated with atopic dermatitis.

Dupilumab is being developed jointly by Regeneron and Sanofi Genzyme, the specialty care global business unit of Sanofi.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organised 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.

References

[1] European Medicines Agency Committee for Medicinal Products for Human Use (CHMP). Summary of opinion (initial autorisation) for Dupixent / dupilumab. Available at : http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004390/WC500231797.pdf (Accessed July 2017).

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

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

[4] 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:  July 2017).

[5] Sanofi. Data on File. July 2017.

[6] National Institutes of Health (NIH). Handout on Health: Atopic Dermatitis (A type of eczema) 2013. Available at: https://www.niams.nih.gov/health_info/atopic_dermatitis/default.asp..( Accessed: July 2017).

[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] Simpson et al. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. NEJM, vol. 375, pp. 2335-23348, 2016.

SOLO 1: Available at: https://clinicaltrials.gov/ct2/show?term=solo&cond=Atopic+Dermatitis&rank=3. (Accessed July 2017).

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

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

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

[12] Medicines and Healthcare products Regulatory Agency Guidance. Apply for the early access to medicines scheme (EAMS). Available at: https://www.gov.uk/guidance/apply-for-the-early-access-to-medicines-scheme-eams. (Accessed July 2017).

Date of preparation: July 2017 - Job bag number: SAGB.DUP.17.07.0857

Updated: July 21, 2017

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