TORONTO, Dec. 4, 2017 /CNW/ - Sanofi Genzyme, a Division of sanofi-aventis Canada Inc. and the specialty care global business unit of Sanofi, announced today the Health Canada approval for Dupixent™ (dupilumab) for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.2 This is the first biologic therapy in Canada to target the root cause of atopic dermatitis.
Atopic dermatitis, a form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin.3,4,5,6 Moderate-to-severe atopic dermatitis is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.7 Itch is one of the most burdensome symptoms for patients and can be debilitating.8 In addition, patients with moderate-to-severe atopic dermatitis experience a substantial burden of disease, including skin lesions, intense pruritus, and impact on quality of life components, such as impaired sleep and symptoms of anxiety and depression.6,9
"Canadians with moderate-to-severe atopic dermatitis often cope with chronic, intense, and sometimes unbearable symptoms that significantly impact their daily lives," says Amanda Cresswell-Melville, Executive Director of the Eczema Society of Canada. "Dupilumab provides an option to patients unlike anything they've ever had before, and this is a significant breakthrough for patients."
Dupixent 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 atopic dermatitis.10 Dupixent is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.
The approval of Dupixent is based on data from the global LIBERTY AD clinical program, which included three randomized Phase 3 pivotal trials known as SOLO 1, SOLO 2 and CHRONOS (enrolled 2,119 total adult patients with inadequately controlled moderate-to-severe AD, (including 274 Canadians). SOLO 1 and SOLO 2 examined the use of Dupixent alone, while CHRONOS looked at the use of Dupixent with topical corticosteroids in patients. In all three studies, Dupixent alone or with topical corticosteroids provided rapid and sustained improvement in lesion extent and severity, itch intensity and health-related quality of life measures, specifically:11
The most common adverse events included injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips.16
Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose.17
"The approval of Dupixent represents Sanofi Genzyme's commitment to the atopic dermatitis community, who have been suffering the burden of their condition," said Peter Brenders, General Manager, Sanofi Genzyme Canada. "This treatment provides patients with the first approved medicine for relieving the debilitating burden for those suffering from moderate to severe AD."
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
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1 Dupixent™ (dupilumab) Product Monograph. Page 22 (Figure 3). November 30, 2017.
2 Dupixent™ (dupilumab) Product Monograph. Page 3. November 30, 2017.
3 Eichenfield et al. Guidelines of Care for Atopic Dermatitis. AAD 2014, pp. 118.
4 Guideline to treatment, European Dermatology Forum. http://www.euroderm.org/edf/index.php/edf-guidelines/category/5-guidelines-miscellaneous?download=36:guideline-treatment-of-atopic-eczema-atopic-dermatitis. Accessed November 27, 2017.
5 Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis- all you can do from the outside. Page 19.
6 National Institutes of Health (NIH). Handout on Health: Atopic Dermatitis (A type of eczema) 2013. http://www.niams.nih.gov/Health_Info/Atopic_Dermatitis/default.asp. Accessed November 27, 2017.
7 Mount Sinai. Patient Care Atopic Dermatitis. Available at: http://www.mountsinai.org/patient-care/health-library/diseases-and-conditions/atopic-dermatitis#risk. Accessed November 27, 2017.
8 Zuberbier T et al. Patient perspectives on the management of atopic dermatitis. J Allergy Clin Immunol vol. 118, pp. 226-232, 2006.
9 Torrelo A et al. Atopic dermatitis: impact on quality of life and patients' attitudes toward its management. Eur J Dermatol vol. 22(1), pp. 97-105, 2012.
10 Dupixent™ (dupilumab) Product Monograph. Page 3. November 30, 2017.
11 Dupixent™ (dupilumab) Product Monograph. Page 16. November 30, 2017.
12 Dupixent™ (dupilumab) Product Monograph. Page 18. November 30, 2017.
13 Dupixent™ (dupilumab) Product Monograph. Page 19. November 30, 2017.
14 Dupixent™ (dupilumab) Product Monograph. Page 23. November 30, 2017.
15 Dupixent™ (dupilumab) Product Monograph. Page 22. November 30, 2017.
16 Dupixent™ (dupilumab) Product Monograph. Page 6. November 30, 2017.
17 Dupixent™ (dupilumab) Product Monograph. Page 9. November 30, 2017.
SOURCE Sanofi Genzyme
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