GUILDFORD, England,
March 14, 2017 /PRNewswire/ --
PRESS RELEASE -
CORRECTION
Positive scientific
opinion under Early Access to Medicines Scheme
(EAMS) recognises burden of
severe atopic dermatitis and
the significant unmet need
of patients
Sanofi, and its specialty care global business unit, Sanofi
Genzyme, announced today that the UK's Medicines and Healthcare
Products Regulatory Agency (MHRA) has granted dupilumab, an
investigational treatment for atopic dermatitis (AD), a positive
scientific opinion through the Early Access to Medicines Scheme
(EAMS). The decision means that eligible adults with severe AD can
access dupilumab before the drug is granted marketing authorisation
in the UK.
"The EAMS positive scientific opinion from the MHRA is
an important development for people with atopic dermatitis,"
said Carla Jones, Chief Executive,
Allergy UK. "Allergy UK supports patients with a range of
allergic conditions, including atopic dermatitis, and we see the
impact this debilitating, life-altering condition can have
on people's day-to-day functioning, making
simple tasks such as dressing or bathing difficult. These
individuals have suffered for most of their lives with widespread
inflamed skin, intense itch and sleep disturbances, often causing
symptoms of anxiety, depression and a sense of
isolation."
"People dismiss atopic dermatitis as
'just a skin condition', but it is much
more than that. Atopic dermatitis is a chronic, systemic,
inflammatory disease that can have an immense impact on
sufferers' lives," said Prof Michael Cork, Consultant Dermatologist,
Professor of Dermatology and Head of Sheffield Dermatology
Research, University of Sheffield.
"Up until now, doctors have had little to offer even the most
severe patients beyond an escalating routine of topical
treatments and immunosuppressants. Dupilumab
targets an underlying cause of the condition and
gives us a new treatment approach for patients with the
most clinical need."
The aim of EAMS is to provide early availability of innovative
new unlicensed medicines to UK patients that have a high degree of
unmet clinical need. The medicines included in the scheme are those
that are intended to treat, diagnose or prevent seriously
debilitating or life-threatening conditions where there are no
adequate treatment options.[1]
Previous products approved under EAMS have mainly been for
life-limiting conditions, such as cancer. The inclusion of a
treatment for atopic dermatitis, a type of chronic eczema,
recognises how debilitating this condition can be and how much
impact it can have on people's physical and psychological
wellbeing.
Under EAMS, dupilumab is being made available to eligible adult
patients throughout the UK who have severe AD that has failed to
respond to all currently approved therapies, as well as patients
with severe AD who are intolerant of, or ineligible for, all
approved treatments.
AD (also known as atopic eczema) is the most common form of
eczema.[2] It can present on any
part of the body, and the inflamed and dry skin that is symptomatic
of the condition, and the symptoms of potential infections, can be
extremely difficult for people to deal with, both physically due to
the pain and discomfort, as well as psychologically, socially and
emotionally. AD can be painful and itchy, and affect a person's
ability to sleep, to concentrate, their personal relationships,
their confidence to socialise, and their
career.[3] This is not widely
understood in society, where it is often viewed as a purely
physical condition. Many patients express feelings of frustration,
embarrassment and anger about their
appearance.[3]
"Sanofi is committed to ensuring that people who
really need dupilumab have access to it as soon as possible
- which is why we applied for EAMS. MHRA recognising the
innovation that dupilumab represents for people living with atopic
dermatitis is a significant step forward,"
said Dr Jasmin Hussein, Head of
Atopic Dermatitis and Asthma, Sanofi Genzyme UK & Ireland.
Dupilumab is currently under joint development with Regeneron
and Sanofi and its safety and efficacy have not been fully
evaluated by any regulatory body. The formal EU regulatory
application for dupilumab is currently under review by the European
Medicines Agency (EMA).
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.
If approved, dupilumab would be commercialised 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
- 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 March 2017).
- NHS Choices. Atopic Eczema (Atopic Dermatitis). Available at:
http://www.nhs.uk/conditions/Eczema-(atopic)/Pages/Introduction.aspx.
(Accessed March 2017).
- Anderson RT, Rajagopalan R. Effects of allergic dermatitis on
health-related quality of life. Curr Allergy Asthma Rep 2001; 1(4):
309-315
SAGB.DUP.17.03.0301(1) Date of preparation:
March 2017