(EURONEXT: SAN) (NYSE: SNY)
TORONTO, Feb. 8, 2018 /CNW/ - Dupixent™ (dupilumab) is now
available in Canada for adult
patients living with moderate-to-severe atopic dermatitis (AD)
whose disease is not adequately controlled with topical
prescription therapies or when those therapies are not
advisable.1
AD, a form of eczema, is a chronic inflammatory disease with
symptoms often appearing as a rash on the skin.2,3,4,5
Moderate-to-severe AD is characterized 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.7
Dupixent is the first biologic therapy to target one of the main
root causes of the inflammation underlying AD rather than to only
treat symptoms of the disease. In clinical trials, patients saw a
clinically significant improvement in the condition of their skin
and reduction in itch after four months of biweekly
treatment.8 Phase 3 trials for Dupixent included 274
Canadian patients in 34 investigation sites across the country.
"Dupixent is the first and only systemic therapy approved for
atopic dermatitis. During the trials, we saw a dramatic improvement
in patients with almost a third of patients who received Dupixent
reaching a primary outcome of clear or almost clear skin," says Dr.
Kim Papp, dermatologist and trial
investigator in Waterloo. "Availability of new therapies like
Dupixent will change the lives of many of our patients."
Beyond the physical aspects of AD, a recent report from the
Eczema Society of Canada found
almost nine in 10 (87 per cent) AD patients believe their daily
life is negatively impacted by the condition.9
Specifically, the report revealed that AD contributed to patients'
loss of sleep (79 per cent), anxiety (64 per cent) and depression
(44 per cent).10
"Often the perception of atopic dermatitis is that it's 'just
a rash,' but this disease has a significant impact on patients and
their quality of life," says Amanda
Cresswell-Melville, Executive Director, Eczema Society of
Canada. "Patients have been
suffering with significant burden, including insatiable itch,
painful rashes that bleed, ooze and crust, lack of sleep, and
missed days of work. New treatment options for the
moderate-to-severe patient population is a very exciting
development."
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
AD.11 Dupixent is being developed by Sanofi and
Regeneron under a joint collaboration agreement, and will be
commercialized in Canada by Sanofi
Genzyme, the specialty care global business unit of Sanofi.
Dupixent was approved by Health Canada on November 30, 2017. The approval was 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). 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.12
Dupixent comes in a pre-filled syringe and can be
self-administered as a subcutaneous injection every other week
after an initial loading dose.13
"Dupixent's availability represents Sanofi Genzyme's
commitment to reducing the burden of Canadians living with AD,"
says Peter Brenders, General
Manager, Sanofi Genzyme Canada. "This treatment will offer patients
the opportunity for relief from the often-debilitating aspects of
the disease and improve the quality of life for adults living with
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
References
____________________________
1 Dupixent™ (dupilumab) Product Monograph. Page 3.
November 30, 2017.
2 Eichenfield et al. Guidelines of Care for Atopic
Dermatitis. AAD 2014, pp. 118.
3 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.
4 Gelmetti and Wolleberg, BJD 2014, Atopic dermatitis-
all you can do from the outside. Page 19.
5 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.
6 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.
7 Zuberbier T et al. Patient perspectives on the
management of atopic dermatitis. J Allergy Clin Immunol vol. 118,
pp. 226-232, 2006.
8 Dupixent™ (dupilumab) Product Monograph. Page 22
(Figure 3). November 30, 2017.
9 Eczema Society of Canada. (2017). Atopic Dermatitis Quality of
Life Report (Moderate-to-Severe Disease – 2016/2017 Survey
Results). Keswick, Ontario.
10 Eczema Society of Canada. (2017). Atopic Dermatitis Quality of
Life Report (Moderate-to-Severe Disease – 2016/2017 Survey
Results). Keswick, Ontario.
11 Dupixent™ (dupilumab) Product Monograph. Page 3.
November 30, 2017.
12 Dupixent™ (dupilumab) Product Monograph. Page 16.
November 30, 2017.
13 Dupixent™ (dupilumab) Product Monograph. Page 9.
November 30, 2017.
SOURCE Sanofi Genzyme