Patients saw a clinically significant improvement in the condition of their skin and reduction in itch within the first four months of biweekly treatment1

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."

About Dupixent

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

In the SOLO 1 and SOLO 2 studies, treatment with Dupixent 300mg as monotherapy every two weeks provided significant improvement in lesion extent and severity and itch intensity:

At 16 weeks, a significantly greater proportion of patients randomized to Dupixent achieved an Investigator's Global Assessment (IGA) 0 or 1 ("clear" or "almost clear") response and achieved a 75 per cent reduction in their Eczema Area and Severity Index (EASI). 12



Additionally, at 16 weeks, 41 and 36 percent of patients who received Dupixent achieved a greater than or equal to 4-point clinically important improvement in the daily intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), compared to 12 and 10 percent with placebo. 13





In the CHRONOS study, treatment with Dupixent 300mg every two weeks together with topical corticosteroids (TCS) provided rapid and sustained improvement in lesion extent and severity, itch intensity and health-related quality of life measures at 16 and 52 weeks, when compared to placebo with TCS:

At 16 weeks, 69 percent of patients who received Dupixent with TCS achieved a 75 per cent reduction in their EASI, compared to 23 per cent of patients receiving placebo with TCS. 14



At 16 weeks, a greater number of patients saw a clinically important improvement of ≥ 4 points on the Pruritus NRS from baseline to week 16 and week 52 compared to placebo + TCS.15

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."

About Sanofi

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.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

In Canada, we employ close to 1,900 people. In 2016, Sanofi companies invested $130 million in R&D in Canada, creating jobs, business and opportunity throughout the country.

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. Learn more at www.sanofigenzyme.ca.

References

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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

For further information: Media Relations Contacts: Maggie Wang Maric, Tel.: +1 (416) 667 2955, [email protected]; Marsha Rosenberg, Tel.: +1 (416) 849 3192, [email protected]