GUILDFORD, England,
July 21, 2017 /PRNewswire/ --
FOR UK MEDIA
ONLY
First
investigational targeted biologic in the European Union to receive
positive CHMP opinion for atopic dermatitis
Sanofi and its specialty care global business unit, Sanofi
Genzyme, today announced that the 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],[4] Within 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. [5] Moderate-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.
Contacts:
Media Relations
Stefanie Holman
Sanofi UK & Ireland
Tel.: +44-01865-405-200 or +44-07740-935-273
stefanie.holman@sanofi.com
Ainsley Cooper
Chamberlain Healthcare PR
Tel.: +44-0207-611-8065
ainsley.cooper@inventivhealth.com
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).